Pfizer

Patient was discharged at 1:25 came back at 1:36 with itchy rash on forearm, given Benadryl 50mg IM. Assessed by doctor working clinic at 2:15, rash was fading and itching resolved. No breathing or airway issues, was discharged.

I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.

No symptoms or pain with initial injection. I came home about 2 hours after the injection and took one 200mg ibuprofen and one 500mg acetaminophen and put an ice pack on the site briefly. Later that afternoon I developed pain at the injection site that progressively got worse over the course of the evening so bad that I could not raise my left arm of touch the site. I put an ice pack on again and that night I slept with a heating pad on. I would rate the pain 8/10. When I woke the next day the pain was still there, but not as severe. I got in the shower and let the hot water beat on the injection site and that seems to help a lot. The pain gradually lessened over the course of the day to a 2/10. By the following day (3rd day post injection) the pain had completely subsided. There was no redness or swelling at the site and I did not have any other symptoms other than the intense injection site pain.

* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight

12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.

Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.

Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising noted. Ice applied and patient monitored for over 30 minutes. Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time. Patient will notify her physician of this reaction to the vaccine.

Red, itchy rash to both upper and lower extremities and upper back. Started 1/01/2021 to present. Treated with prednisone 60 mg x 5 days and trimcinolon 0.025% topically

Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.

Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.

hand was swollen and itchy on the same arm where the injection was; back of hand was swollen and itchy on the same arm where the injection was; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (Deltoid Right) from 26Dec2020 15:00 at single dose for Covid-19 immunization. The patient's medical history included chronic pain and insomnia. Concomitant medications included hydrocodone and temazepam. The patient reported, "On 26Dec2020 I got my first immunization for COVID and today (30Dec2020) I woke up and the back of my hand was swollen and itchy on the same arm where the injection was". The patient further stated "It never have happened before I don't have any reaction at the injection site but it was kind of odd that it kind of showed up on the back of my hand, it feels like an allergy kind of thing." The patient tried the Voltaren Gel to try and get the inflammation down, but it didn't help, and she took some Benadryl it doesn't seem to help much. The patient's next shot is due on "12Jan2021". The outcome of events was unknown.

Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; This is a spontaneous report from a contactable other-HCP (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included pulmonary embolism and known allergies: penicillin. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), vitamin b complex (VITAMIN B), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), tocopherol (VITAMIN E), received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine administered was in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 14:45, the patient experienced golf ball size swelling below the injection site. Arm was red and itchy. No treatment received for the adverse event. Outcome of the events was recovering. This report was assessed as non-serious. Information about Lot/batch number has been requested.

intensely pruritic rash, starting around neck initially and then presenting in perianal area, moving up lower back with sharp linear demarcations, also perinasal bilat . Also on eyelid with periorbital edema rt>lt. Typical appearance of contact derm with raised indurated intensely pruritic lesion except almost exact opposite in distribution (flexoral/internal aspects of skin) and no known exposures. Now day two and rash is becoming more well demarcated, more red and inflamed and spreading in distribution face, neck and lower back. There is no logical explanation for this rash.

30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.

Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.

APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXTREME FATIGUE AND HEADACHE ADN THE INJECTION SITE WAS PAINFUL. I HAD THE COVID VIRUS DIAGNOSED 10/23/2020 WITH THE EXACT SAME SYMPTOMS EXCEPT I RAN A HIGHER TEMP

arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol. The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy. The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."

chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.

Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Diphenhydramine HCL VS 178/85, 72, 18, 98% O2sat. at 1340 states she felt better.

Had initial vaccine on 12/21/2020. Broke out in rash reported in a previous report file. After 2nd injection, at some of the exact locations of healing rash from 1st, new eruptions of red raised pruritic rash occurred. Lower abdomen, top of right ribs and nape of neck.

Approximately 24 hrs after injectio rash occurred to groin area & lower abdomen. Then appeared in multiple patchy areas. Over next 10 days rash appeared on right of mid sternum, right upper ribs, coccyx area, nap of neck. Rash was small red bumps any extremely pruritic

1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading

Patient reported soreness/painful up into clavicle area of right side where injection occurred. Patient also reports swollen and painful lymph nodes on right side where injection occurred.

On the 3rd day after the injection I felt a burning sensation on the skin of my neck then with in 10 minutes the feeling spread over my whole body. Not an itch just a burning and slight red patches on my: Neck, upper back and inner side of my arms. It wasn't like a hot flash I was expecting hive welts but that didn't happen.

Patient developed a rash on her neck beginning on the right side and continued to increase around her neck. She is still experiencing redness today. She also has some itching of her scalp. She did not require intervention.

Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.

Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on her neck and chest. Denies difficulty breathing however she reports her throat is very painful, scratchy, dry and irritated. For treatment patient took a zyrtec 24 hour 10 mg tablet on 1/11/21 which reduced some inflammation of rash, however still present 1/12/21. Has increased fluids, is taking tylenol and tea with honey. These were self care done by patient. MD suggested to Zyrtec every 6-8 hours as needed for symptom control. Ibuprofen / tylenol as needed for headache if no provider has told you not to use these in the past. If any progressive Sx than you should be seen at URI clinic.

Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM, I noticed a rash on my left upper arm/deltoid at the vaccine site. Rash is flat and red, approximately 8 cm x 8 cm, but not circular.

Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (arm left) on 08Dec2020 (lot unknown) at SINGLE DOSE; and second dose via an unspecified route of administration on 06Jan2021 at SINGLE DOSE (lot number EJ1685) for COVID-19 immunization. The patient medical history was not reported. The patient was taking unspecified concomitant medications (same medications that she usually takes and has not started anything new). Patient reported that she was fine after the first shot. Her arm was a little sore on Dec2020 and that was it. The soreness at the injection site lasted 2 days and then recovered completely. She has no breathing difficulties or anything similar. Outcome of the event "Her arm was a little sore" was unknown while recovered for " The soreness at the injection site lasted 2 days" on Dec2020.

4 days after receiving Covid shot in left arm, shingles appeared on right scapula area, 3 days later shingles appeared on right upper lateral arm form shoulder to forearm

Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained of head tingling and body itchiness.

Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.

Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.

10 minutes after receiving vaccine pt. c/o severe itching on face and neck. No hives, shortness of breath or distress noted. Pt. declined to take Benadryl or Epinephrine - requested to go to hospital for evaluation.

I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.

About 15 minutes after injection c/o mild tingling to lips. No other symptoms. VSS (BP 103/68, O2 99%, RR 17, HR 68). no wheezing, SOB, swelling, chest pain, dizziness, abd pain, NV. about 15 minutes later, lip tingling improved but began c/o generalized urticaria with mild erythema to left upper chest. patient well appearing at that time, A&Ox3, no increased WOB, SOB, hives, facial swelling, facial redness. Patient reports she experienced same urticaria about 24-48 hours after 1st COVID vaccine dose, treated at home with po benadryl with improvement. Placed on continuous monitoring and administered 25 mg Benadryl po with improvement in symptoms. About 30 min after benadryl administration symptoms resolved. Offered ER evaluation to which patient declined. She works within hospital and agrees to seek emergency medical care should symptoms return or worsen. can continue to take benadryl at home and monitor closely.

Soreness at injection site x 48 hours--no treatment Slight twitching in left eyelid x 48 hours--no treatment--still have a little twitching in the eye but seems to be getting better

I received the Pfizer COVID-19 vaccine on 1/7/21 which resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On Friday, 01/15/21 a couple hours after exercising (elliptical and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up Saturday, 01/16/21, the redness, soreness, and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to Urgent Care, which I did and was prescribed Doxycycline for possible cellulitis. Today, 01/18/21, sx's have much improved.

patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.

6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING. 1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE

began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face

Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching

Injection site got really red started about a quarter in diameter and swelled to about 9 inches in diameter. Itched and was painful. Lasted about 1 weeks time. Ibuprofen and diphenhydramine.

1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums

taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever

BRUISING, IT STARTED ON LEFT THIGH AND WENT TO LOWER LFT ABDOMEN WITH FIRST INJECTION. AFTER 2ND INJECTION IT WENT TO THE RIGHT THIGH AND HAD SMALL BRUISES.

12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.

Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days

7 hours after the injection, I broke out in hives in my torso. Over the next 2 days, it has spread to my whole body. I am taking Benadryl to try to relieve the itching.

I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

25 minutes status post the vaccine patient experienced head itchiness. Patient was brought to the triage room and had fine rash on chest. BP noted to be 190/90, HR 60, RR 16, sat 100%, and no SOB/difficulty breathing. Allergy on call was paged and patient was given zyrtec. After given zyrtec patient was monitored for two hours. There was a redness on patient's neck which was continually lessened, HR, RR, and sat remained stable throughout. Sat remained between 150-170 for the next hour. After 2 hours the redness on neck has completely resolved and BP 153/79. Allergist on call notified. Plan was to have patient go to ER if she experienced SOB, chest pain, or headache.

Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myalgias; This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 22Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced very swollen and erythematous arm, chills, severe neck pain, myalgias, all on 22Dec2020 14:00. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment given. The outcome of events was resolved. Facility type vaccine: Hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. Not known allergies or other medical history.

Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.

Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.

1 hour after vaccine -itchy injection site and small rash starting on top of left arm, took 50mg of Benadryl 1 hour after Benadryl- rash was spreading to the whole arm , neck and intermittent labored breathing started patient was taken to hospital and received 2 doses of epinephrine and nebulizer treatment

Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM, I noticed a rash on my left upper arm/deltoid at the vaccine site. Rash is flat and red, approximately 8 cm x 8 cm, but not circular.

First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose on 1/9/21: Approximately 53 hours after Dose #1: Redness on hands and wrist, rash-like small dot appearance on hands and wrists, skin dryness and tightness of hands. I experienced no itching of hands or wrists. Approximately 53 hours after Dose #2: Small, painful red pustule-like occurrence on base of right thumb, with the appearance of a few small dots in it. I experienced no itching of thumb or hand. These events both occurred within the same timeframe following the vaccine doses. Following the first event I was seen in the ER. I checked out fine and they could not say exactly what this was. They said it did not appear to be an allergic reaction to the vaccine because it was not systemic and I had no other symptoms such as trouble breathing. They thought perhaps it was coincidental...I work in the hospital as a radiologic technologist where I hand-wash and hand-sanitize all day. Perhaps I just over-washed that day? However I've worked there for 17 years and never had this happen. The redness and rash dissipated by end of day. Following the second event I did not follow up with any medical provider. This pustule I got happened while I was at home, and otherwise I felt fine so I left it at that. It took several days for the pustule to go away. I hope you don't mind but I am writing to report this information in the event it may be helpful to you and I am also reporting it because I want to know if what I experienced could be considered an immune response to the vaccine? Another words, not an allergic response but an immune response ? I can find absolutely nothing about this on-line and no one knows what to make of it. Thank you.

RASH STARTED 2 DAYS AFTER VACCINE ON MY WRISTS, AND SLOWLY WENT UP MY ARMS BY SUNDAY MORNING. BY MONDAY MORNING RASH WAS ON MY LEGS, CHEST, BACK AND ARMS. ITCHY, RED AND RAISED WELTS IN PLACES. JUST UNCOMFORTABLE. IT'S NOW WEDNESDAY AND IT'S SLOWLY GOING AWAY, STILL RED AND ITCHY. I DID NOT GO TO MY PCP. I DID SHOW MY RASH TO MY INFECTIOUS DISEASE PHYSICIAN AT OUR HOSPITAL. I HAVE BEEN TAKING AN ANTIHISTAMINE THAT HAS HELPED.

like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was "like an anaphylactic reaction but not in her throat." itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9. I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.

Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes of each other and now to be re-vaccinated again the second dose; not enough research can guarantee if that's safe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140, expiry:Mar2021), intramuscular on 12Jan2021 at a SINGLE DOSE then intramuscular on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased, fistula, surgery on 18Dec2020. It was stated, "Sure, I am hoping you can help me. I am one of the legal guardians for our younger sister who has special needs. She is residing in a group home, group home in the city area she is currently been out of it because she has surgery. They have made arrangements for them to still ask for them to receive the first Pfizer Covid 19 Vaccination just this past Tuesday so I go from up there from my home in city and we had a problem in there they screwed up and ended up vaccinating her twice within 10 minutes. I asked the pharmacist, there I asked the RN what does that mean for her I mean I didn't know what that meant but normally we would sat for 15 minutes, they made her sat for 30 minutes. The nurse was there from the group home monitored her blood pressure and temperature and then we got in the car proceeded to drive 3 and half hour. They said just watch for temperature, labored breathing, take her to the emergency room call 911, the only thing she did have about an hour after she broke out that was "malar" (not clarified) rash across her face part of her cheeks over her nose that lasted for about 30 minutes. The next day her arm was sore which was going to happen but here is my question though she received two vaccine within 10 minutes of each other and now they are wanting her to be re-vaccinated again which would have been the second dose, supposedly on 02Feb2021. Nobody can tell me if that's safe or if that's okay, they can't guarantee, they all kept telling me, the nurse says, I called the pharmacist kept saying there's not been enough research to know if it's safe for her to get that next vaccine, so I don't know what to do." The reporter also stated, "IM, Both went for IM, first one went into her left arm and second shot was given in her right arm." The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on an unspecified date, blood test: unknown result on 05Jan2021, body temperature: unknown result on an unspecified date, sars-cov-2 test: unknown results pre-surgery and post-surgery. The outcome of the event rash across face, part of her cheeks over her nose was recovered and arm sore was unknown.

tongue on the side is bruised; it was a big black spot that she noticed this morning while brushing her tooth; right arm being sore started after 1.5 hours after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose in the right arm for covid-19 (immunization). There were no medical history and concomitant medications. Patient had got her Pfizer Covid vaccine on 13Jan2021 and thought she had a reaction and wanted to know if anyone had this reaction. On 14Jan2021, patient stated on right side where got shot on that her tongue on the side was bruised. She stated that her arm hurt last night. She stated this was her first dose. She later clarified that it was her right arm. Patient stated that it was a big black spot that she noticed this morning while brushing her tooth (14Jan2021). Her right arm being sore started after 1.5 hours after the shot (13Jan2021). No treatments received in response to the events reported. The events "tongue on the side was bruised" and "it was a big black spot that she noticed this morning while brushing her tooth" were not recovered. The outcome of the event "right arm being sore started after 1.5 hours after the shot" was recovered on 14Jan2021.

Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache

itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued and plateaued for hour and half. Benadryl and prednisone given in ED. Monitored and D/C with no further progression of sx.

I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to feel malaise and fatigue. Upon waking around midnight, I had developed a 102.4 degree (F) fever, total body ache, headache, chills, and cough. Most symptoms lasted approximately 24 hours. The headache, although now mild, persists into the third day. On the third morning following the injection, I woke to find a slightly painful triangular-shaped red, raised patch on the same arm as the injection (left). The "rash" measures approximately 4.5 cm x 7 cm.

6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.

Patient received their first dose of Pfizer vaccine on 1.27.2021. Patient reports little red spots that are itchy on their legs, thighs, and chest that started the day after receiving the vaccine. The patient states that they are NOT experiencing any facial swelling, scratchy/itchy throat/ShOB. Patient states the rash has improved with over the counter medications. Encouraged the patient to reach out to provider with any more worrisome or bothersome conditions, including worsening of rash. Reviewed when the patient should seek emergency care.

Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she developed an itchy rash on her left arm which became panful. She saw her PCP who diagnosed shingles.

headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness at injection site, some wheezing 40 x 40 mm

Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.

noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK9231) at single dose on left arm on 03Jan2021 at 0830AM for COVID-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Medical history was none. Family medical history was none. Relevant test was none. Prior Vaccinations (within 4 weeks) was none. There was no concomitant medication. Patient received 1st dose on 03Jan2021. Yesterday (18Jan2021), she noticed 3 lumps the size of finder tip on her shoulder that were red and itchy. Across her cleavage, she noticed another 3-4 lumps. She noticed last night, 18Jan2021, three lumps on her shoulder that were really itchy and red and three or four across her cleavage area but not as large. She was just checking, she knew it said could have swollen lymph glands. Patient mentioned she tried to set the phone thing set up where they call you but she could not do it. The shoulder lumps were on her left side and about the size of tip of her little finger. She tried Witch Hazel; she rubbed it on and that soothed it a little at that time. she was scheduled for the second dose of the vaccine on the 25Jan2021. Patient asked if this was normal and what could the end result possibly be. The adverse events did not require a visit to physician or ER. The outcome of events was not resolved.

Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2. Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.

Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.

FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOURS

slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; at the site of vaccination was redness, soreness, and heat; possible cellulitis; This is a spontaneous report from a contactable other HCP. A 60-years-old female patient receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 16:45 at single dose (lot number: EK4176) for covid-19 immunisation. Medical history included hypertension (HTN), anxiety, arthritis, seasonal allergy, known allergies: Penicillin, Sulfa, Bactrim. No covid prior vaccination. Concomitant medication included losartan, citalopram, cetirizine. The patient experienced vaccine resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On 15Jan2021 a couple hours after exercising (elliptical use and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up 16Jan2021, the redness, soreness and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to (urgent care withheld) which she did and was prescribed Doxycycline for possible cellulitis. Today 18Jan2021, redness, soreness, and heat have much improved. Treatment received for the events. Events resulted in physician office/clinic visit. Outcome of events was recovering.

Developed Itching and feeling of tightness in back of nose/throat. Advised employee to go to ED. Was given 1L fluid, Solu-Medrol and Benadryl. No swelling of airways was observed and no respiratory distress noted. ED discharged patient to home.

minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.

admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her left arm. There was a small area that had a lace modeling appearance. Patient denied any pain or itchiness to this area and there were no hives. Patient very anxious and concerned and asked if she could take her own liquid Benadryl which she had on hand. She was offered Benadryl from the clinic but refused and really wanted to take her own. Approval from supervisor obtained and Benadryl was verified. VS BP 110/60, HR 76 and pulse ox 98% at 2:35 pm. Patient denied any other signs and symptoms of allergic reaction except anxiety. VS repeated at 2:55pm and were; BP 110/60, HR 68, Pulse ox 100%. No change in condition and patient felt good enough to leave. Patients sister accompanied her to the clinic today and will stay with her tonight.

Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 97% Lungs clear.Client called family to pick her up and take to her PCP.

Nothing major. A weeping painful welt to the right of injection site started overnight on the day of injection. Did not report Subsided several days later

Developed rash at back. Resolved spontaneously at one week post vaccination. Vaccine #2 given 3 weeks later @ 2/7/21. Rash reported when patient came in for Pfizer vaccine #2 (after resolved). Did not report to healthcare system or present to medical care for evaluation.

Pt had vaccine at about 1pm, did well, went back to work. At 2pm, pt came back to say she was itching all over arms, back hands, scalp. BP 138/62, gave one diphenhydramine 25mg po. At 2:15-- same symptoms, no worsening. At 2:30pm, per pt less itchy; NO n/v; NO thickening feel of tongue/throat; pt will take Allegra at 6pm; will notify Dr/ER if any worsening of symptoms

injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient). A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.

left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Monday 2/1. She reports the area is red right after the vaccine. She reports she has had increased swelling, redness, warmth. She reports she did have reaction to her first vaccine with redness and swelling, but that occurred 10 days after. She reports she has had some fever and body aches that she associates with having the second vaccine. Constitutional: Negative for chills and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Negative for cough and shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for joint swelling and arthralgias. Negative for back pain. Skin: Positive for color change. Negative for rash. Neurological: Negative for weakness and numbness.

her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.

The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED

Axillary lymph node-grape size, on side of injection site painful, movable and tender 5 days after the vaccine injection. No longer tender but still same size

fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.

The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine. It is still there but not as bad as it was initially. I googled skin conditions and it looks like Livedo reticularis. I went to my Cardiologist on 2/5/21 and he took bloodword CBC, Prothrombin Time and bloodwork was normal. Cardiologist told me to go to a dermatologist. My arm was sore also where the injection was and it was hard to lift my arm. That lasted one day. I also had aches and pains and was fatigued on 2/3/21 for 24 hours.

For about 24 hours soreness in left arm near injection site, more swelling and a lump under left arm and burning sensation under left arm and chest area where I typically have swelling and numbness due to lymphedema post mastectomy. Resolved within 24 hours with no treatment.

on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweating, lethargic with muscle aches and pains along with temp. Temperature returned to normal in pm on 2/7/2021. Muscle aches and pains, itchy at injection site and being tired lasted another couple of days. Feeling back to normal by 2/10/2021

Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.

Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All over body aches worse than flu, fatigue.

pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.

On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right eye, the right ear, and the teeth on the right side also hurt. Nothing helped taking Acetaminophen; Ibuprofen. She went to sleep around 4:00 am finally, and then woke up 6 hours and the headache was gone. Then you had hives located behind the right ear and down the neck, into the right shoulder. They are also in her scalp. They have now down to the tops of her legs, hips, and back and are spreading. She called her doctor who called her in some prescriptions.

Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vaccine - a rash that itched. It lasted about 4 or 5 hours - I put Calamine lotion on it and that soothed it. I also experienced a little itching of eyes and a slight itching in mouth. About 9:30 pm I had a rapid heartbeat for about 30 or 40 minutes. The itching sensation continued off and on the next day but bumps weren't visible any longer. The itchy eyes continued off and on for the next day as well.

Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration on 26Jan2021 at 02:30 PM in left arm at single dose for COVID-19 immunization in the workplace clinic. There was no other vaccine administered in four weeks. Medical history included gluten intolerant. No Known allergies. Concomitant medication included calcium, ergocalciferol (VIT D), ibuprofen (ADVIL), multivitamin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient experienced soreness at site of injection and loose bowels on 27Jan2021 at 07:15 AM. No treatment was received for adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was not recovered. No follow-up attempts possible. No further information expected.

8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.

Patient was premedicated with Zyrtec 10 mg at 2:15 prior coming to her second appointment. She reported similar symptoms from pfizer Vaccine first dose after 25 minutes of observation for the second vaccine. Reported slight itchiness and facial redness. sightly less than previous dose. The allergist on call was notified, ordered Zyrtec 10mg. Zyrtec 10 mg a/o. Initial BP 176/76 HR 64-sat 100% RA. . BP186/80 - HR 54. HR 60 BP 168/78, Observation 1:1 by RN maintained. BP prior dc 152/79 Hr 58.

The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection site, about the size of a 0.50 cent piece. Later that day I had a fever of 102.5 and chills. Day 3 the redness had spread and still had the lump. Day 4 or 5 the color changed to purple and the lump had decreased. It took about a week for the lump to go away. I still have a discoloration on my arm where the vaccine was given. It looks a bruise but no pain. The whole time the area blanched well. The first dose I had on my left arm and the next day I had a small welt with redness. I am on my second round of steroids to try and get my asthma under control and had to increase my Advair to the highest dose. My doctor put me on a antibiotic as well with the second round of steroids. My asthma is a little better but not at my baseline.

2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs, down thighs at bedtime, under arms), rash was spreading, pt put calamine lotion on rash, woke up 2/17/21 and rash is gone.

This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injection now. The pain wakes me up at night. Sometimes in the day I feel the pain level at about a 6.

2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tiredness, - Tylenol every 5 hours 2/14: fever 99 F, body ache, headache, tiredness, hives on chest, stomach, back, arms, - Tylenol every 6 hours 2/15: no fever, hives fading out 2/16: tiredness, hives cleared up

Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation

The vaccine was not injected into the muscle as prescribed. The nurse pinched up the fat on my arm with a short needle. My upper arm swelled almost to the size of a baseball and was red and painful for over one week. I think it was administered SQ although intended to be IM. I am a nurse and thought to myself at the time of injection that the proper technique for administering the shot was not followed, but thought perhaps I could be wrong and the extra swelling might be normal with the second injection. My first injection was in left arm and did not swell and was only sore for a few days. If administered SQ, will the vaccine dose be effective?

Pt reported slight tongue "tingling" and also has a small patch of flat erythematous area on her skin about 8 minutes after the vaccine was administered. She does report the reddened area is itchy. She denies SOB, denies airway tightness, denies chest pain. Her vitals at 1356 hours are a HR of 66, BP of 139/74, RR of 18, Sats 100%, RR 16. Pt took a PO benadryl at 1347 hours per her request as she had already declined further EMS care (ALS and ambulance declined). Her Sxs resolved by 1356 hours. She stayed a few more minutes to be sure her symptoms were completely resolved and left POV at 1407 hours. She will follow up with her physician as soon as she leaves. She has been notified that her symptoms could return.

I had the shingle injection in between the two covid injections. I've had a itchy rash for 6 weeks on my legs and torso. Some raised welts and some regular rash. Nothing over the counter seems to help much.

Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty breathing but felt like she had to take off her mask to get "air", slight numbness in the arms and felt flushed.

1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order received to administer po benadryl 25 mg po 1030 symptoms resolving continued to monitor for additional 30 min. 1100 pt stable and symptoms resolved left premises this time.

Itchiness and Rash: Multiple body areas: between and under breasts, lower back area, under arms. It was also on my left arm around the injection site but that has gone away. Date of 1st dose: 1/8/2021 - ELO140 Date of 2nd dose: 1/29/2021 - EJ1686

Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.

While in observation area, patient reported to EMT a rash and itchiness in abdominal area. EMT notified lead nurse on site. EMT assessed patient and reported blood pressure 142/90 mmHg, regular pulse 60 bpm, and respirations 16 breaths per minute. Patient denied difficulty breathing, difficulty swallowing, and chest pain. Patient revealed history of allergies to unspecified medications. Patient offered diphendyramine. Patient refused diphenhydramine. Patient advised to wait 15 minutes for further observation. Lead nurse assessed patient. Patient reported decreased itchiness and denied difficulty breathing, difficulty swallowing, and chest pain. Patient advised to seek emergency care if symptoms progress. Patient left observation area with steady gait.

Rash on neck last for one week. After one week, small bumps still remain 10 days later. Bumps are focused vertically from chin

swelling at the site; redness at the site; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EU9899), via an unspecified route of administration in the left arm on 30Dec2020 at 15:00 as a single dose for COVID-19 immunisation. Medical history included anemia, diabetes mellitus, blood cholesterol abnormal, blood pressure abnormal, and low FE. The patient had no additional vaccine/s administered on the same date as BNT162B2, had no prior vaccinations within four weeks, and had no family medical history. Concomitant medications included liraglutide (VICTOZA; taking for 8 years), labetalol (taking for 20 years), diltiazem (CD taking 20 years), valsartan (DIOVAN; taking for 20 years), rosuvastatin (taking for 10 years), metformin (taking for 20 years), aspirin [acetylsalicylic acid] (taking for 10 years), and iron; all are ongoing. On 30Dec2020, the patient experienced swelling at the site and redness at the site. The patient stated that after the first dose, she noticed a little bit of swelling and redness at the site that went away in 48 hours. She had no relevant tests done. The events did not require any visit to a physician or to the ER. Outcome of the events was recovered.

I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,

Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.

Metallic taste in mouth that dissipated after about an hour, redness/swelling at injection site and itching that persisted for 3-4 days.

Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.

Red, itchy, bumpy, swollen rash on right shoulder extending to right breast. Swelling of left hand, stiffness, hard to move fingers, same rash as above between fingers.

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next day it spread partly down my arms and legs. On day 6 I had malaise and fatigue and lessening of rash.

left arm became red and tender 2 days after the shot- and has continued for a total of 3 days without change

Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as well as headache for 24 hours. One week later, severe joint pain for 48 hours.

swelling, itchy spots: , itchy knot on hip, itchy spots: under breasts, ears, and palms-- swollen lips

On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.

Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.

This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.

Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9265, via an unspecified route of administration, in the right arm, on01Feb2021 11:30 at SINGLE DOSE for covid-19 immunization. Medical history included diabetes, high cholesterol, high blood pressure and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced soreness at injection site on 01Feb2021 11:30. The outcome of event was recovered. No follow-up attempts possible. No further information expected.

Within 15 minutes after 2nd COVID-19 mRNA vaccination (Pfizer) today, patient reported itching of left forearm (vaccine administered in left deltoid), which then also started in right arm and upper back. Slight redness noted on left forearm where patient had been scratching but no visible hives or rash. Patient denied any difficulty breathing, shortness of breath, throat tightness or itching. Diphenhydramine 25mg PO x1 dose administered. A few minutes after diphenhydramine administration, patient reported that her eyes had become itchy. 20 minutes after diphenhydramine dose, patient denied any worsening of symptoms, reported lessened itching and opted to leave clinic.

mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.

On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.

sever headache itching over entire torso both began about an hour after injection. Lasted through the evening and night Took Tylenol

Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.

burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologist on 2/24 for biopsy (gluten rash, psoriasis) and was prescribed Clobetasol 2x day. Rash dried up with skin flaking and peeling in about 5 days. Second vaccine received 3/4, no rash as of 3/10

raised, red rash bilateral hands from inside of thumbs to mid-forarm. provided 50mg of diphenhydramine. observed patient for additional 30 minutes. rash decreased in severity and there were no other symptoms (difficulty breathing, increased heart rate, etc)

FLARE OF A RASH ON MY LOWER LEGS, HIGHLY INFLAMED AND SWOLLEN, DR. PRESCRIBED TRIAMCINOLONE ON 02/12/21. IT IS BETTER BUT NOT GONE AT THIS TIME.

Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 05Feb2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231) on 13Jan2021 at 01:45 PM for COVID-19 immunization (in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 06Feb2021 at 02:00 AM, the patient experienced fever ranging from 100 to 100.9 accompanied by chills and moderate headache as well. Fever subsided by the morning of 07Feb2021 and headache was mild by then. The patient also experienced soreness at site of injection on 06Feb2021 at 02:00 AM only if she touches it. No treatment was administered for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.

Itchy rash looks like mosquito bites on legs, stomach and arms; soreness at injection site, tiredness

Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9

Patient was receiving an IVIG infusion at the time of reaction. Patient has had infusion many times in the past with no reaction, so we are possibly attributing the reaction to her recent COVID vaccine. Severe hives/boils from neck to knees Itching IV methylprednisolone was administered in the home to control reaction. Her MD prescribed famotidine and loratadine to assist with relieving her symptoms.

whole body sever itching. Scratched shin raw, back had hives, abdomen continues to sporadically itch. Never experienced itching of this nature this before. MUCH BETTER, but not fully resolved. (My Mother had same response to her second Moderna COVID19)

I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will call my doctor tomorrow morning.

red rash around injection site soreness at injection site had bump on injection site body aches headache

Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine was administered. Today, 03/14, woke up feeling very sore and around 11:45am I began to feel chills, body aches, headache and fever.

Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slept over 3 hours between 11am and 3pm) Severe pain at the injection site and muscles surrounding it (approx. 8pm) continuous as of this report (3/14/21 12:45am) Pain in the lower left jaw (approx 9pm) continuous as of this report (3/14/21 12:45am)

INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 CHILLS 3/12 & 13/2021 JOINT PAIN 3/11/12/13/2021 FEVER 3/12/13/2021 102.5 & 100.2 FEELING UNWELL 3/12/13/2021 I JUST KEPT TAKING TYLENOL TILL I FELT BETTER. I AM FINE TODAY. 3/14/2021

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

Within 30-40 mins, I had a raised red mark starting at the base of my throat running up to my left nostril. There was a lighter red mark on the right side that stopped just above my chin. There was no burning, itching or soreness associated just the raised red marking. It started to dissipate within 2 hours

Injection site warm, raised, and red; Injection site warm, raised, and red; Left arm felt bruised after she got the injection; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9262, first dose) solution for injection intramuscular in the left arm on 08Feb2021 at 12:00 (at the age of 60-years-old) at single dose for COVID-19 vaccination. Medical history included obesity, arrhythmia (that was fairly under control, and was not life threatening) and palpitations (palpitations from time to time, but this medication did not cause that). Concomitant medications included escitalopram oxalate (LEXAPRO) and lisinopril. Historical vaccine included flu vaccine in Oct2020 and experienced bruised after the injection. After the vaccination, the patient experienced injection site warm, raised, and red on 08Feb2021. The patient experienced left arm felt bruised after she got the injection in Feb2021. The patient has had no treatment for her arm yet. The outcome of the events injection site warm, raised, and red and left arm felt bruised after injection was unknown.

This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of the Pfizer COVID-19 vaccine. She felt fine right after her vaccination but as she drove to her destination where she was going to take a walk, she started to develop left-sided facial burning and swelling. That prompted her to call her PCP in that office recommended she come back to the vaccination clinic to be evaluated. I evaluated her at approximately 2 PM.. She was feeling well for the most part with the exception of left-sided facial burning and swelling and a little bit of redness over her left cheek. She denied fevers, chills, itching, other areas of rash, difficulty speaking, difficulty swallowing, tongue swelling, lip swelling, wheezing, chest pain, or difficulty breathing. She recalls a penicillin allergy at age 5 or 6 but cannot remember the reaction. She has never reacted to a vaccine before. Initial vital signs included a blood pressure of 134/73, a pulse that was 70 and regular, and an oxygen saturation of 100% on room air. She had normal mental status and her lungs were clear. The left side of her face was slightly swollen over her left cheek as compared to the right with some slight increased flushing on the left side. There was no stridor, she was speaking comfortably, and her lungs were clear with good airflow. Her heart demonstrated S1 and S2 with regular rate and rhythm. I administered 2 doses of Benadryl, 25 mg with each dose about 15 minutes apart with her last dose at approximately 2:25 PM. I rechecked her vital signs at 2:50 PM and her blood pressure was 138/79 with a pulse of 70 and regular and an oxygen saturation of 99% on room air. Her lungs were clear and she was moving good air. I did take a relook at her face which was improved with decreased swelling. At 3 PM, because she was doing much better, I discharged her to home with instructions to use Benadryl 50 mg when she got home and then 25 to 50 mg every 4 hours today. If she develops any respiratory symptoms such as difficulty swallowing, cough, breathing difficulty, swollen tongue or swollen lips, as well as increased facial swelling, she will call 911 to be evaluated. She should not get the second Pfizer COVID-19 vaccine.

About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.

3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.

Allergic reaction to COVID-19 vaccine (rash on stomach - left side) Began 03/08/2021 cleared up and then reoccurred 03/11/2021 still evident 03/16/2021

40 hours after COVID-19 mRNA vaccination patient awoke in the middle of the night with itch, swelling, rash on left eyebrow. Subsequent 6 days rash developed into typical herpes zoster (shingles) rash localized over left eyebrow.

60 yo woman who 3-5 minutes post vaccination developed facial itching and erythema, initially in her eyes and nose. Administered 50 mg diphenhydramine PO. In the minutes thereafter, the pruritis spread to the upper lip, then face and scalp, and became more generalized (but mild) on limbs. She also reported a "dry throat" sensation, but denies throat tightness or itching and did not have any respiratory compromise for the hour that she remained under observation. Symptoms subsided and patient left the facility. Followed up with her later by phone to inform her that her immediate allergic reaction was a contraindication to her receiving the second Pfizer COVID-19 vaccine and that she should not return for a second appointment. Advised that she seek allergist consultation given her history of multiple allergies, and to determine whether there was a common substrate for any of them. Said that she could possibly consider the Johnson&Johnson vaccine thereafter, if she did not have any known allergies to components of it.

generalized pruritic rash and redness, patient describes symptoms as "red and blotchy" Patient taking Benadryl to relieve symptoms. Recommended to see primary provider if symptoms worsen.

Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and neck. Very red and itchy. Went to pharmacy to get Benedryl and pharmacist suggested to go to ER immediately. Went to ER and was evaluated and kept for observation. No swelling of tongue or difficulty breathing. Stayed for observation and given prednisone (deltasone) . Given an epi pen and instructed to take benedryl. Hives subsided. No reactions since that night. Arm a bit sore but nothing severe. Seeing an allergist next week as followup.

I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the shot. I started having what looked like bruising all along the veins in my arms and hands. Still have that. I went to the doctor and also found that I had high blood pressure and an elevated heart rate. BP 140/90 and Heart rate 85. My normal heart rate is between 55-60 and my usual blood pressure is 108/70. The doctor gave me a steroid shot. This morning, my blood pressure and heart rate were still high and I still had a headache. Then the headache stopped and I took my blood pressure and it was down to around my usual 108/70 and the heart rate was 60. So hopefully I'm starting to recover from this shot.

Patient presented to ER around 5pm on 3/13 complaining of skin itching - this involved the forearms, chest, under her breast, lower back and trunk. She took Claritin and used hydrocortisone cream before coming into the ER. She received diphenhydramine 50mg PO and prednisone 60mg PO in the ER. she was discharged home with prescriptions for Zyrtec 10mg, Diphenhydramine 50mg a Prednisone taper.

Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone

Date and time adverse event started: 3/18/21 1520 immediately 1707 Caller states about 2 hours ago called was given Pfizer in the Left deltoid. Felt slight pain then when needle withdrawn started bleeding. Pressure was applied for about 45 minutes dressing changed two times. now has a band aid over the area. Area is starting to bruise and the patient is getting a headache. Patient has a grape sized hard knot at the injections site. Patient using ice indirectly for 10 minutes on 10 minutes off. Caller questions if vaccine went into the blood stream will it be effective, or does the vaccine need to be placed in the muscle to have time to replicate to be effective. . Does caller need another first shot.

Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very sore. The pain is very localized and responded to a couple of days of ibuprophen. Started again this week and the arm is swollen/inflammed. Uncomfortable for daily activities like typing or eating. Does respond to ibuprophen. Trying to rest it and have it in sling to rest it.

Itching mostly on upper body, chest back, arms &neck w/o rash started on 3/11/2021 & stopped on 3/15/2021

The patient's arm was slightly red in color and swollen. When felt, there seemed to be a lump where the vaccine was given after 5 days.

swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.

Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache

3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something. Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid. Was discharged with prescription for Epi Pen, Zyrtec, and Pepcid. Still have rash and hives but not as extensive, comes and goes.

8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.

Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chills, felt unwell

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated started next day, reddness, used coritsone and the spot began to grow, now is red and hot to touch, but no longer painful. Thinks it may be celluilitis and is going to check with primary MD as follow up.

Rash and hives, itchy and swollen lymph node on right neck - appeared approximately 24 hours after second dose of vaccine. Received one shot of steroid and prescribed a 6 day dose of oral steroid.

About 45 minutes after the injection two large spots on the face had hives, moderate swelling beneath right side of lip, minor swelling beneath left side of lip. Took Zyrtec and symptoms went away.

Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted about two days

She started noticing about an hour and a half after she got her vaccination that the injection site started turning red and her arm started swelling from her shoulder down to her hand. She has started taking Advil and icing her arm. It has improved since the evening after she received her vaccination.

Extreme arm pain, swelling at injection site as well as intense itching. Used extra strength Tylenol, store brand antihistamine and extra strength Benadryl cream.

At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.

Pfizer-BioNTech COVID-19 Vaccine EUA: nine and thirteen days after vaccination patient evaluated for persistent, raised, pruritic rash on chest. Patient reports reaction is similar to previous allergic reactions to shrimp. Did not take any medications to treat rash prior to first evaluation. Patient denies wheezing, dyspnea, fever, chills, myalgias, arthralgias, bleeding, nausea, mouth sores, and angioedema. Vital signs within normal ranges. Patient advised to use diphenhydramine.

Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 14Feb2021 at 12:30 at single dose for COVID-19 immunization. Medical history included allergies to dust mites, dogs, and corn; Hashimoto's thyroid; and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. She was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluvoxamine maleate (LUVOX), thyroid (ARMOUR THYROID), and amlodipine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced swollen face, swollen puffy eyelids and below the eye, and itchy rash on face, neck, and chest on 14Feb2021 at 17:30. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was told to take ALLEGRA and PEPCID in the morning and CLARITIN AND PEPCID in the evening by the allergist. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were assessed as non-serious. Information on the lot/batch number has been requested.

She has shoulder injury related to vaccine administration with decreased range of motion of shoulder, pain at deltoid and pain with overhead activities that persists, albeit some improved, for 2.5 months post vaccination

Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).

At approximately 11:05, patient, reported to her vaccinator that she had a reaction of rashes and itchiness after she received the first dose of Pfizer BioNTech Covid-19 Vaccine (LOT# EN6198; exp. 06/30/2021) on 02/27/21 at 10:59 AM. Vaccinator immediately reported to lead nurse at vaccination site. Lead nurse assessed patient history. Patient reported reported itchiness on torso, scalp and left breast approximately 5 minutes after first dose. Patient offered oral diphenhydramine in observation area. Patient declined diphenhydramine. Patient went home and stated she noticed redness and rashes before going to bed. Patient reported redness and rashes extending from deltoid to elbows on both left and right arms. Patient took bendadryl to alleviate symptoms. Symptoms lasted for approximately 3 weeks. Patient also reported no reaction to prior vaccinations. Patient reported talking to her doctor after first dose. Patient advised to apply hydrocortisone cream before 2nd dose of Pfizer and to take benadryl after 2nd dose was given. At approximately 11:11 lead nurse elevated situation. Lead nurse advised to not give patient her 2nd dose of Pfizer, offer Janssen as her 2nd dose, and recommend patient to see an allergist. Patient agreed to take Janssen as her 2nd dose. Lead nurse recommended patient to see an allergist and took patient contact information to set up her appointment for Janssen as her second dose.

Pruritis, shortness of breath Patient to the hospital via EMS. Vitals remained stable and lungs clear. Vitals upon discharge 164/99, HR 86, oxygen saturation 98%. Patient was observed until 12:15pm and was wheeled out to her transportation service.

this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.

After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat had begun to also hurt at that time. EMT's came over to assess her, per the nurses request the EMT's at that time suggested to the patient that she be further evaluated at the hospital. She accepted the transport to the ER.

Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was told to take Tylenol for fever and if it didn't drop to the walk in or ER. It finally dropped later that evening. Then the next day 3/22 i have a rash on my arm i received the vaccine in. On 3/24 it was worst. put a call back into the doctors. Said if it continues to get worst to go to the ER. I put ice and cortisone cream on it which helped take the itching away.

Itching from my head that progressed to my knees by early afternoon. No hives or anything else. Resolved after two doses of benadryl about 4 hours apart. Woke up next morning feeling fine.

Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021

2nd dose of Pfizer COVID vaccination at 1pm. Had sudden onset itchiness, erythema, difficulty breathing and lip swelling at 7pm. Brought to ED, given epipen and methylprednisolone. Monitored closely overnight, symptoms resolved by AM.

Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.

1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under right arm Outcome not known yet, swelling and redness seem to be lessoning.

Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.

Swelling, redness and itching in arm pit of left arm and into lymph nodes. itching only when rubbed.

itchy welts on legs and arms, lasting for 4-5 days after, after 2 nd dose, one left leg and arm again lasting for 4-5 days, then then staring again on the 17th of March.

rash; itchiness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration, in the right arm on 26Feb2021 at 15:45 (at the age of 60-years-old) as single dose for COVID-19 immunisation. Medical history included cardiac murmur, allergy to walnuts, and shellfish, allergy to penicillin, bilateral stenosis of ureters, and obesity; all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received unspecified concomitant drugs within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine and experienced drug hypersensitivity. On 26Feb2021 at 17:00, the patient experienced rash and itchiness. The patient was given diphenhydramine (BENADRYL) as treatment for the events, rash and itchiness. The patient recovered from the events, rash and itchiness on an unknown date.

Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering. No follow-up attempts are possible. No further information was expected.

pt. c/o of tingle on her lip & back of her throat a little redness on nose & cheeks. no shortness of breath. lungs all clear & vitals BP=142/88; P=82; O2=95%. Hx= tachycardia

Pain at injection site, extreme back and body aches, headache, dizziness, low grade fever. Ibuprofen & Acetaminophen As of 4:00pm on following day of injection, reactive symptoms still occurring...

Severe pain where shot was administered for 3 day. Very Bad Sinus Headache for 4 days. I still have this symptom not as severe but every time I cough I get the pain in the center of my forehead or if I bend to get something from the floor. I never had this before till I received the first shot.

Important to share: I had a strong case of Covid in March, 2020. No hospitalization and no need to go to hospital but I was very sick for three weeks. Oddly, after Covid I had odd heart pains and erratic high blood pressure. I saw a cardiologist and my heart was fine but it lasted on and off for months. I've been very well for months now. 1) The day after the shot, I felt tired and had a headache, which is expected and no big deal. The evening after the shot I experienced a lot of pain around my heart area. It was very similar to what I experienced post-Covid but more painful. It hurt enough that I went to the ER at Hospital in because of the chest pain. EKG, chest x-ray, and all blood tests were normal. 2) The next day, I fell asleep on a hammock in my backyard. I was wearing jeans and a sweater so the sun wasn't directly on me but I noticed later that the outside of my R leg and the inside of my L leg were covered in a red, lacey-looking rash. Oddly, my arms and torso had no rash. I called my Internist (Dr.) who asked me to email photos. She said it looked like an allergic reaction to the vaccine and advised me to submit info on this site and to take a benedryl. The rash was definitely where the warm sun hit me.

After developing blood blisters in my mouth and a rash on my feet & legs, I phone the Advice Nurse and had a phone consult with Dr. I had a blood test the following morning and recieved a call the next morning at 5:40 a.m. directing me to my local Emergency Department as my platelets measured only 16. I checked in 3/30/21 and following a new blood test showing my platelet count was down to 2, a Gastroenterologist diagnosed me with severe ITP. I then was treated with prednisoone, plasma transfusion and IGG (i think) infusion. An additional blood test showed my platelet count rose to 50. A CT scan showed no abnormalities.

Fatigue- 36 hours Fever (100-102) -48 hours Chills - 48 hours Sore/red arm at injection site - 1 week

Headache chills fever upper respiratory cough, muscle aches, earache, stomach ache, pain at injection site and itching

I woke up the morning after my second Pfizer vaccine with severe body aches, chills, mild headache, low-grade fever, puffy injection site that felt warm to the touch and hurt. The worst of it was the whole body aches and chills, which made me feel like I have felt in the past when I have had the seasonal flu. The symptoms lasted all day, with the chills finally leaving by around 10 pm. By the following morning, so about 48 hours after the shot, I felt pretty much normal. I was told I could get these side effects, and don't think they are unusual per se, but thought it was my duty to report them for longitudinal studies.

Site soreness immediately following vaccine which dissipated quickly. HOWEVER, 4 days AFTER vaccine experienced extreme vertigo, dizziness, nausea which required an ER visit. Side effects still lingering next day.

Low grade fever; itchy throat and face/slight hives, cold compress; few hours Tues: fatigue; Wed: okay; Thurs: all day diarrhea; Fri: morning diarrhea; Sat. okay; Sun and Monday; Sneezing and runny nose; Tues: runny nose

Medical Information Potential AE; rash on her lower stomach area; This is a spontaneous report from a contactable consumer (patient). A 60 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 Immunization. The patient's medical history and concomitant medication were not reported. It was reported that Yesterday morning patient developed a rash on her lower stomach area. Patient wanted to know she could treat this at home with cortaid or anti itch cream or should she see her family physician and get an antibiotic. The outcome for the events was unknown. Information on the lot number and batch number has been requested.

The day after the vaccination, there was pain on my left side (my vaccine shot was in my right arm). By Saturday 3/27/21 (day 4), a localized rash appeared on my left side (midriff area) which looked like herpes blisters. The area was sensitive to touch and painful. The pain had spread to my left back area. Started 1000 mg Valacyclovir 3 times a day on 3/30/21, after I saw the doctor and she confirmed it was probably shingles. The rash and sensitivity/pain are still present today, 4/2/21, on day 10 after the vaccine.

Fever of 102.5, swelling in left arm with redness exceeding three inches by 2 inches in left arm, chills, extreme fatigue

Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported vitals from ER BP=107/70, Liver tests were off due to dehydrated per ER , had fever ,sweats then chills and Headache followed by fatigue for a few days. Patient did notify her PCP

Left forearm rash. Using Tylenol, topical numbing cream. See previous vaccine adverse event recorded this AM. No changes. Advised to contact PCP if rash is getting worse.

Lump at the injection site the size of a plum and pain in the area. Slowly subsided, but took 1 week to no longer have a visible lump or pain and soreness.

Flushing /redness of face starting 50 minutes after vaccine Hot feeling of face & mouth & slight tingling in mouth that lasted 3-4 hours Low grade fever 99.4 about 3-4 hours after vaccine All resolved within 5-6 hours

rash on thighs, abdomen and back. Large red spots. do not itch. do not break open. just spots. increased lethargy

It started as small itchy bumps on my right arm at elbow. Progressed to welps and finally a rash over my right arm. It never moved beyond the arm. I googled when I realized it was my vaccine arm. I have had allergic reactions before, but this was limited to my right arm. Found a condition called COVID Arm.

Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.

early AM, pea size lump at injection site, itching which grew to a date size lump with reddening and hot to touch by 5PM same day. lump and redness grew larger over next few days, with itching sensation. red mark the size of a grapefruit (5"). no pain in arm at injection site, yet swelling/lump and very large red covid burn.

Day 1 - within 5 minutes I felt extremely sleepy and my eyelids were heavy 15 - 20 minutes of receiving the vaccine, I was experiencing itchiness - like hives or from allergic reaction (I had them previously from allergy test reactions and allergic reactions). It was generally all over, but then I started itching under my arms. At that point, we informed the medical person who was monitoring our waiting section. He asked if I had any Benadryl, and I responded that I did. I took 12 ml (?) of Benadryl liquid and the effects subsided somewhat. I slept and when I woke up, I was itchy again and my stomach was cramping. I took more Benadryl and over the next 5 days got better.

chills; body aches; under arm/neck/torso/inner thigh rash; diarrhea; This is a spontaneous report from a contactable consumer (patient reported herself) reported in response to non-HCP letter sent in cross-referenced case. A 60-Year-old female patient received second dose of BNT162B2 (COVID 19, Pfizer/BioNTech, Formulation: Solution for injection, Lot number: EL3247, Expiration Date: May2021) via an unspecified route of administration on 16Feb2021 02:45 PM at single dose to her left arm for Covid-19 immunization. Facility type vaccine: Workplace clinic. The patient's medical history was not reported. Known allergies included gluten intolerant. Historical vaccine details included: product: COVID Pfizer, vaccine date: 26Jan2021, lot number: EL3247, vaccine location: arm left, Expiration Date: May2021, time the vaccination was given: 14:24 (24hour clock), anatomical location of administration of Pfizer vaccine considered as suspect: arm left, events: soreness at site of injection and loose bowels; fine now; did not receive any treatment. Concomitant medications included lisinopril, MULTIVITAMIN, ongoing ergocalciferol (VIT D), ongoing calcium and ibuprofen (ADVIL) from an unspecified date to an unspecified date. Covid was not tested prior or post vaccination. On 17Feb2021 01:45 PM, the patient experienced chills, body aches, under arm/neck/torso/inner thigh rash and diarrhea. Outcome of the events was not recovered.

12:35PM STATES SHE IS LIGHT HEADED; FOREARMS RED - PLACED ON FLOOR WITH FEET ELEVATED.12:40 MOVED TO COT PER WHEELCHAIR. A/O, PINK, W/D, RESP REG WITH EASE. 12:48 'FEELS BETTER'. 1:50PM FEELS BETTER - HUSBAND HERE TO DRIVE PT HOME. NO REDNESS TO ARMS; NO ACUTE OR OBVIOUS DISTRESS NOTED.

Started feeling unusual burning in right arm ( opposite from vaccine side), from wrist to elbow then elbow to shoulder. Attributed it to tennis elbow from strenuous hitting, then got raised welts like hives following evening on right shoulder. Rash appeared and I started to suspect shingles. ( have never had before) saw doctor on 3/30/2021 and got shingles diagnosis. I believe it is due to the vaccine and have spoken to multiple medical professionals that believe there is a connection. I have had racing heartbeat, numbness on right side of face, severe pain in right ear.

Pfizer-BioNTech COVID-19 Vaccine EUA I received my 2nd shot on 3/26 in my left arm. I had no reaction to either shot. On Thursday, 4/1 I got a rash on my lower right arm. I had just used a Brillo pad to scrub a pot. Although I have used them many times with no problem, I thought maybe the soap got on my arm and irritated it and didn't think anything of it. As the day went on, the rash got more red, burned, and started to form tiny blisters. I had Clobetasol Ointment home and put that on it. The blisters started healing but the rash is still red. On Sunday, I felt an irritation on the same arm but near my arm pit. When I got home, I found a similar rash (2 patches). This burned just like the other rash. I put the same ointment on. Now I thought I better research because it seemed odd. I read about other rashes but they were on the same injection site arm. I thought I better report this just in case it is from the shot. The original first patch is still red but does not burn.

Itchy hand, wrist and ankles, small lumps 50+ size of pea or smaller started 6 days after vaccination. Continued 4 more days (today) as they turned red, blistery, bubbled, popped, skin pealed on the larger areas (less than the size of a dime). Moved up to shoulders, and on legs up to thighs. Possible one on tongue. Antihistamine will take down the itchiness although initially adding Benadryl too.

Itchy skin followed by rash with bumps and itching under both arms. The rash has not gotten better in fact it's worse now then it was when injection was first received.

Received shot on Friday afternoon. On Saturday morning had sore arm at injection site. Then developed very achy shoulder, with ache spreading up neck and down back on left side. Some fatigue as well. Aches dissipated after a couple of hours, but fatigue continued and worsened on Sunday and continued into Monday. Also on Monday, woke up nauseated, and it continued, on and off, throughout the day until bedtime. Nausea gone on Tuesday, but still a bit more tired than usual.

Small itchy rashes but not at the site of the the shot in upper right arm. Rash started two days after 1st shot given on right side upper arm. Rashes only on left side of body on right thigh, right wrist and right side of face. No other side effects. A few smaller spots popping up four days after shot on right thigh. Rashes are small and one the wrist is very itchy - mild rashes. No treatment from healthcare provided was needed.

Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner, around 7:30pm I noticed that my lips were swollen and the rash was spreading. Took one Benadryl and waited 1 hour. Condition worsened so left for ER around 8:45pm. Once there, I was diagnosed with an anaphylatic reaction. I was given Prednisone, Pepcid and Benadryl intervaneously. The Benadryl injection caused my throat to close for a few seconds. Things calmed down so we waited an hour to see if I was responding. There was not a lot of improvement so ER doctor decided to use Epinephrine (EP pen injection). After 2 hours of observation, I was set home to follow up with primary care physcian.

Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneous report received from a contactable consumer. A 60-year-old (age at vaccination) female consumer reporter for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; ER8727) via an unspecified route of administration on 23Mar2021 at 11:45 am at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Patient's medical history included COPD mild (Chronic obstructive pulmonary disease) and allergies to medications, food, or other products (unspecified). Concomitant medications included (received within two weeks of vaccination) inhaler and vitamins (drug name unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Hives including 1 that was blister like, redness or arm, itching and arm soreness on 23Mar2021 at 01: 15 pm. Self- warm compression initially then iced was the treatment given. It was unknown if the patient was diagnosed with covid-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The outcome of events was unknown. information on lot expiry has been requested.

Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Error: Infection / Cellulitis (diagnosed by MD), Additional Details: pt says went to md cellulitis at injection site due to not given in correct spot

3/10/21?first shot. Felt fine. 3/19/21?started to get rash on upper left arm?shot arm. 3-20-21?rash spread to upper right arm and a few spots on my knees 3/23/21?blood draw. Platelets almost doubled since my last count three weeks prior. Increase anagrelide to two pills twice a day. 3/31/21?second dose. Shot again the left arm Felt fine that day. 4/1/21?felt tired. 4/2/21?really feel tired and skin feel tingly like a rash coming on. Had chills. By evening upper arms were red, sore, swollen, rash covered and warm to the touch. 4/3/21---Slept a lot of the day and still in a fair amount of pain. Upper arms and hands red, sore and swollen. Took an over the counter antihistamine Zyrtec, which helped with the swelling. 4/4/21?Continued with Zyrtec 4/5/21?Continued with the Zyrtec. Skin in my arms seems to be ?drying out? a bit and swelling down. 4/6/21?Arms and hand still red but swelling down.

Lower right leg vein popped out about 1/2-3/4" - didn't feel anything; Lots of petechiae from back to feet; Blood blisters; Turned into bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Mar2021 21:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included allergies: anesthesia and thrombocytopenia that developed during childbirth (went away after a few weeks). The doctors said that it may have been a drug reaction. Concomitant medication included omeprazole (PRILOSEC). The patient previously took codeine and experienced allergies -severe nausea. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 08Mar2021 18:00, patient's lower right leg vein popped out about 1/2-3/4" but did not feel anything. It later turned into a bruise. Lots of petechiae from back to feet and blood blisters noticed; large on torso. AE resulted in: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for AE. It was also reported that the events caused hospitalization. Platelets were tested last week (unspecified date in 2021) and are on low end of normal range. Outcome of the events was unknown. Information on the lot/batch number has been requested.

The evening after I got my last pfizer covid 19 shot , I felt a red , hot rash, on my right buttock. It was not raised. I did not seem like hives. I took Benadryl . I slept the night. It was a little less red the next day. Then, around 2pm the next evening (4/7) I had another red patch on my other buttock.

On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then there was a rash all around my thigh. The pain is still present and the rash has gotten worse. I went to my doctor on 4/6/21 and he says the event is caused by the vaccine. He said the symptoms resemble shingles but also varies from shingles.

Patient reports of feeling flush. She reports she feels she has a rash on her hands. Reports of shortness of breath, Blood pressure elevated and elevated Heart rate. Duration: 30+ minutes.

Fever ranging from 99.5-101.5, fatigue, loss of appetite, rash, began 24 hours after the shot and continued for 48 hours. Used Advil, which could have been the cause of the rash but I am not certain. I often get rashes when I have a virus, and and Advil seems to make them worse. It was a little unusual in that it spread to my legs and back, as well as my face and torso. It was completely gone after 4 days.

Side of right foot got very red and swollen, then turned to large bruise covering little toe, and part way down foot. Next bruised spread out.

Woke up Wednesday morning and a large square red patch on right arm. When I touch it, the site is warm to the touch. Also, arm is sore. Pfizer shots

Injection site was red, warm, large lump, very itchy and tender on Day 2. I took Tylenol. Day 3 the same. Day 4 today, lessening of the symptoms

Flu like symptoms for two days after. Developed red rash on top of both forearms, Hives in various places on body. Sores inside mouth.

I got shingles 2 weeks after first dose. Doctors say get second dose 3 weeks later (today) but bc I have shingles I?m waiting a week or two. Listening to my two pharmacist friends and my gut/common sense. There are many people with my same story online who have gotten shingles after the first or second dose of the Covid vaccine. I don?t know how there can?t be a connection. My pharmacy?s and two doctors told me the vaccine lowers your immune system so it makes sense you would be more susceptible to getting shingles. One pharmacist said this: The common thing is to wait till it?s gone before second dose because there have been no studies done with patients with shingles and so they say wait till it?s gone just to be safe. If you have active shingles, do not get vaccinated 2nd dose until healed. Even if it is past the 42 days, it?s still fine to get the next shot. Another pharmacist said this: As of 4/8/21, the CDC does not state specifically that you cannot get the shot tomorrow due to taking valacyclovir or due to active shingles infection. In my personal opinion, If it were me I would wait until off the Valacyclovir and the shingles has gone away just to be sure your immune system is at full force. Hope that helps.

Rash. Raised red. Looks like measles. Right arm. Shoulder and back. Very itchy. Taking benadryl and applying hydrocortisone. Rash is still itchy after 2 days. Not going away yet

All over rash and hives and itching on body including face around eyes and mouth, scalp itching and tongue feeling funny at times but no swelling as far as I can tell. As of 04/09/2021 I have started taken Benadryl in hopes that would help. A little headache here and there. Have taken Tylenol for that.

Pfizer-BioNTech COVID-19 Vaccine EUA I had normal pain at the injection site after the shot, which went away after a couple of days. A few days later a different part of that upper arm and shoulder became painful to move certain ways. I saw my primary care physician and he said the shot must have nicked the bursa under the muscle. He diagnosed bursitis and prescribed diclofenac gel.

Muscle soreness at injection site and lymph nodes in left armpit within six hours of vaccination. Lasted three days. Also had overall body aches, fever (up to 101.2) and chills. Lasted approximately 14 hours beginning on 3/31/2021.

tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.

Patient DOB 10/4/1960 was vaccinated on 3/17/2021 with 1st dose Pfizer, lot ER2613 expiration date 6/30/2021. Patient reports medical condition includes hypertension. Allergies include sulfa and amoxicillin. Patient informed RN that after receiving the 1st dose she experienced "itchy thighs" within 3 hours that resolved 3 days later. Patient denied rash, heat, or redness. Medication includes blood pressure medication. RN notified PHN who texted PHN Supervisor, Manager, and QAS. Per medical team patient is to wait until 28 days post 1st Pfizer dose before receiving Janssen vaccine. Patient changed timing of itching to starting the next day after vaccine. Per medical team, patient is advised to consult with her provider first.

Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; Anaphylaxis; chest hurt to breathe; Itching in my arms and chest in the evening.; rash; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 17:00 (Batch/Lot Number: EP8534) as SINGLE DOSE for covid-19 immunisation. Medical history included Only occasional migraines. Never anything like this and known allergies: Some grasses. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, at 8pm, the patient reported that "3 days after 2nd shot I started itching in my arms and chest in the evening. Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor. My rash was worse and spreading and chest hurt to breathe and I had bumps on head so we called # and nurse and my husband drove me to (Name). They gave me an IV and epinephrine shot and Pepcid and did CT scan of head and blood work. Diagnosed Anaphylaxis. They sent me home a couple hours later with prescription for Epi pens Zyrtec and Famotidine. Over the course of Friday my rash/hives got worse and spread over my body and my lips /mouth started to swell. I called the nurse who suggested I come back in and they checked by throat to ensure it wasn't closing up and gave me ibuprofen and Benadryl and sent me home. Rash/hives worse and spread all over body and face when I woke up Saturday morning (today). Plan to see specialist Sunday or Monday." The outcome of the events was not recovered. The patient was not tested for COVID-19 after vaccination.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Thirty minutes after shot, patient passed out and urinated on herself. Plus, had what she discribed as a seizure.

Feeling feverish and achey, hot but not registering any high temperature. Headache. Nauseous and itching at injection site. This all started at 12 hours after the shot, almost to the minute. I have been taking Ibuprofen for the aches and headache, drinking water and eating small meals, trying to rest.

approximately 12 hours after vaccination 4/10 woke up with severe muscle aches, arms, shins, ankles and headache. Also felt nauseous. In morning had very slight fever and sore throat. Overnight on 4/10 woke up with extreme tightening feeling in center of chest Today 4/11 have rash on arm where I received vaccination in an area that covers an oval about 5 x 8". Took Ibuprofen in am for pain then tylenol for slight fever and pain. have marked rash to see if it spreads.

Patient felt itching on hands, back, and face but no hives were present. Oral Benadryl administered. Observed for 45 minutes. Patient felt much better after Benadryl administration.

itching to face and facial flushing. hypertensive 151/108,78, 16,99% RA. After some time the patient Blood pressure improved 146/92. refused transport

First injection on 3/14/21 Migraine Headache, dizziness and mild hives lasting about 24 hours. These symptoms started about 30 minutes after injection. Injection site arm pain starting several hours later and lasting about 2 days. The second dose was given on 4/4/21. Hives starting about 2 hours after injection and more moderate than mild. They are larger. There are many more covering most of my body and they itch. I have had them for 7 days and am managing them with benedril. The second dose also caused mild arm pain at the injection site.

Feeling EXTREME dizziness and nausea that does not let up or subside. Unable to stand. feeling dizzy. Sudden whole body heating up. Face turns red. Symptoms do not get better.

My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very swollen, hard, and painful enough to wake me in the middle of the night. The hard lump was as big & wide as my right hand and began 2 inches above my elbow up to the place of injection. When my morning alarm went off, I was very fuzzy and extremely weak. I was unable to go to work or remember a lock combination I use every day. My energy began to return the next day enough to work a half day but returned to bed for the afternoon. The tiredness was all but gone by 8:30 pm. Reaction began Sunday morning and was gone by Tuesday night.

Arm pain immediately afterwards. Beginning at 18 hours after vaccination: excruciating headache, nausea, diarrhea, elevated temperature/flushing, chills, fatigue, swelling and redness at injection site. Unable to eat or drink anything for 12 hours. Symptoms started to ameliorate after taking 1,000mg of acetaminophen around 28 hours after injection. 48 hours after vaccination, most symptoms had passed except for some residual headache and fatigue. Short fainting spell at 49 hours but did not pass out.

Bleeding at injection site. Seven minutes after being seated for observation, I fainted and vomited while I was out for 5 minutes. An ambulance was called and took vitals for the 20 minutes after I awoke and vitals were all good, so I declined going to the hospital.

Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my back or put on my seatbelt. The are aches so much that I can not sleep at night. I am unable to lay on my left arm. I have a large hard lump on my left arm at the injection site. Weakness in left hand. Unable to raise my arm to remove my shirt. The pain seems to be getting worse. Left inner leg bruises and pain.

u1st Pfizer vaccine on 3/17/21 the next day I only has pain with swollen area in left arm around shot location. My 2nd Pfizer vaccine on 4/7/21 the next day around 4pm I started all the symptoms until chills, aches and pains, fever, and nausea, This was severe Thursday evening and most of Friday. Friday night I had swollen lymph nodes in the armpit and near the collarbone on my shot arm. This was very uncomfortable. Saturday the chills, aches and pains, fever, and nausea started to go away. Sunday mostly swollen lymph nodes and aches and pain in joints. Sunday night swollen lymph nodes stared to go down. Monday am still a bit tired but feeling better

102.9 degree fever off an on for about 18 hours after the first dose. Subsided by 9am the morning after the vaccine. Also, injection arm (non-dominant arm) incredibly sore to the point of not being able to raise it, but deep tissue massaging the site alleviated this symptom by 32 hours after vaccination. Filling this out for data collection purposes. Did not take any anti inflammatory or anti-fever medications to combat. Simply sweated out the fevers and drank lots of water.

4/7/21. Sweating profusely,no fever. 4/8/21 .Swollen left upper arm (2× it's size).Intense itching entire left arm for 24 hours

Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face starting day 2 lasting 2 days. I had a lump behind left ear that lasted 5 days. I have had ringing in my ears, louder in the left ear, since the injection, for 2 weeks now. It is quite loud and annoying. I have recovered from all side effects except the ear ringing.

Rash at injection site, severe itching at injection site, continued headaches, stomach issues, metal taste in mouth, fatigue.

Sweats Abdominal Cramps Body Aches Severe Fatigue Swelling and Redness and Induration and Warmth and Tenderness to Palpation at site of injection after the second shot All symptoms started about 8 hours after the second dose and have continued to today. Today is the first day the symptoms seem to be decreasing in severity a little. Symptoms are worse at the end of the day.

APPROX 2 HRS AFTER VACCINE GIVEN, STARTED TO GET HIVES, SELF MEDICATED WITH BENEDRYL, BY THE NEXT MORNING I HAD SEVERE HIVES ALL OVER MY BODY, CONTINUED WITH BENEDRYL. ON THURSDAY MORNING WENT TO URGERT CARE AND WAS GIVEN STEROID AND ANTI ITCH PILLS. ON SATURDAY SYMPTIOMS WERE NO BETTER SO WENT TO ER CLINIC AND WAS PRESCRIBED PREDNISONE AND ADDITIONAL ANTI HISTIMINES. HIVES WERE COVERING MY ENTIRE BODY AND WERE CAUSEING MY SKIN TO BE A PURPLE, DARK RED COLOR. I AM ON DAY 7, STILL HAVE SPOTS WHERE HIVES HAVE BEEN, STILL ITCH, SKIN IS SORE AND WARM TO THE TOUCH. I HAVE 2 FULL DAYS OF MEDS TO KEEP TAKING.

Moderate soreness at injection site that started 10 1/2 hours or so after I received the 1st shot. The soreness lasted about a day and a half.

04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER8733); noted to be tearful with hand over chest. Voiced "feels like heat is beating fast all of a sudden". 1207 Pt. moved to monitoring cot into semi - reclined position. 1208 BP 140/82, HR 103, O2 sat 99%, R 20. Skin slightly clammy with no skin redness / rash or throat / tongue edema. 1208 EMS called to site. Pt denies medical hx or any allergies. 1213 Pt. voiced "HR starting to feel better, only notes some lightheadedness / spacey feeling; P 91 / Sat 98%. 1215 BP 132/78, P 65, R 18, Sat 98% - Voiced "thinks everything is okay now; notes only dull ache at right arm injection site. Pt. also called husband to site at time. 1217 EMS arrives and pt. assessed. 1226 EMS provided pt. education on self monitoring & hospital f/u. Pt. declines transport to hospital; will monitor self at home with assist of husband: sitting on side of cot. 1228 EMS departed scene and pt. husband now present; P - 61 and O2 98%. 1229 Pt. and husband voiced readiness to leave. Educated to let pt. PCP know about events post vaccination. Pt. voiced understanding and will just monitor self at home. Both ambulated to from site together

Immediate trigeminal nerves triggered, mouth tingled, slightly dizzy, blurred vision. 1/2 hr later felt like skin burning on face and arms looking like a sunburn, small fiber neuropathy kicked up throughout body. Next morning slight headache and slight dizziness, slight sweating. Subnormal temp all day. Burning feeling, sunburned skin continues as it comes and occasionally lessens.

All over rash and hives and itching on body including face around eyes and mouth, scalp itching and tongue feeling funny at times but no swelling as far as I can tell. As of 04/09/2021 I have started taken Benadryl in hopes that would help. A little headache here and there. Have taken Tylenol for that.

pt says that her arm was very sore after taking the vax but then she developed a fist size bruise at the injection site. there is no fever or soreness any longer but the bruise has been there for almost 2 weeks. She went to PCP Dr. on 4/12/2021 and she was told it was not a bruise and to contact the vax manufacturer since he wasn't sure what it was.

Client reported receiving COVID vaccine second dose on 04/12/21 at 1:30 pm, adverse reaction began later that day at 3:30 pm. Client report a rash started on both arms, then felt rash went to her ears, they felt like they were getting bigger as well. Rash moved to other parts of her body such as face, trunk, and legs. Rash is itchy, reddish in color, warm to touch, and very painful all over. Client also report getting the same rash after first COVID vaccine on 03/22, but that rash only lasted 2 days. Client seen by PCP for this recent reaction, prescribed hydroxyzine and a hydrocortisone cream. Client report no improvement and plan to contact PCP again regarding rash.

Pt was given second dose of vaccine on 0412/2021. She developed severe pain of forearm and wrist. She had applied ice to site and today noticed a bruise on her inner wrist (4 x 2 inch). Denies taking any blood thinner and denied trauma. No warmth or pain at this time. She took 800 mg Ibuprofen night before vaccine for back injury. She applied ice to site. PCC: Advised to FU with pcp, urgent care or ED for cbc and coags. Although Pfizer vaccine has not been known to cause clotting issues and sx could be unrelated it is best to r/o. Caller will be going to home on Friday and said she might wait to fu with pcp there.

her eye looks like a bee stung her eyelid, it is swollen; hives on face; rash on her legs and her legs were itching; rash on her legs and her legs were itching; This is a spontaneous report from contactable consumer (patient). A 60-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/lot number: EK9231; Expiration Date 30Apr2021) via unspecified route of administration in right on 11Jan2021 at 16:00 as single dose for COVID-19 immunisation. The patient medical history not reported. historical vaccine included BNT162B2 (First dose: 21Dec2021; Lot number: EL0140; Expiration Date: Mar2021) and concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient reported hives on face that were red and bumpy. They are not as bumpy but it is still red like her face looks sunburned red and her eye is swollen, rash on her legs and her legs were itching, on 03Feb2021 her eye looks like a bee stung her eyelid it is swollen. Treatment received for the events with Prednisone. The outcome of the events (Urticaria, rash, pruritus) was unknown, her eye looks like a bee stung her eyelid, it is swollen was not recovered. Description of Product complaint: Caller was calling about the Pfizer COVID vaccine. She says she wanted to report having a reaction. She had hives, like a rash and her eye looks like a bee stung her eyelid, it was swollen. She had a rash on her face and her legs and her legs were itching, it was like hives on her face that were red and bumpy. They are not as bumpy but it was still red. She has been taking Prednisone and she was not sure if that is why its getting a little bit better but it was still really red and itching and the swollen eye was a new thing. Her Prednisone was in an amber color pharmacy bottle and does not see an NDC lot or expiration on there.

Extreme arm pain began 4/7, Shingle rash outbreak on 4/9, diagnosed with Shinges on 4/11. Prescribed Valtrex for 7 days

Bruising; Soreness and pain in left arm at site; Soreness and pain in left arm at site, under arm pit; Soreness and pain in left arm at site, under arm pit and around breast; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: EL9261) as single dose for covid-19 immunisation (age at vaccination was 60 years). No other vaccine in four weeks and other medications in two weeks were reported. No Known allergies and no other medical history were reporter. Historical vaccine included dose 1 via an unspecified route of administration, administered in Arm Left on 05Jan2021 at 07:45 AM, (Batch/Lot Number: EK4176) as single dose for covid-19 immunisation (age at vaccination was 60 years). Following mammogram 26 days after (as reported) second dose the patient experienced bruising and soreness and pain in left arm at site, under arm pit and around breast on 19Feb2021 at 16:00. The patient recovered with lasting effects. No treatment was received for the events. No covid reported prior vaccination. Covid wasn't tested post vaccination. The patient underwent lab tests and procedures which included mammogram: unknown result. Outcome of events was recovered with sequelae on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported. The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.

Injection on 04/08/2021; On 4/16/2021 injection site in Right Arm became swollen and red like a ?target?, warm to the touch and sore. Reporting on 04/17/2021 so do not know the outcome of said event

itchy lips, then itchy scalp and feet. started 45min after shot. lips may have been swollen or may have seemed that way because of itchiness. I could not see them. lips issues ended within an hour from starting and the rest of itchiness ended after 2-3 hours. headache next day and lifting arm soreness next day.

Shot 1: Site soreness (severe) lasting 1 week, fever, chills, headache, tiredness 48 hours. Shot 2: Site soreness (not as bad as shot 1) for 1 week. 48 hours tiredness, headache, chills, fever. Next 48 hours: tired, headache. One week later starting experiencing dizziness, fatigue, tinnitus. Continuing off and on one month after 2nd vaccine. Have a good then several bad days. Seems to be getting worse and more chronic. Wake up tired but not dizzy and within 45 minutes dizziness starts up and continues through until late afternoon. Fatigue is chronic and fairly bad no matter how much sleep I get. Tinnitus (which I have never had before) is consistent but not super severe. Never had dizzy spells or vertigo before either.

Site injection soreness; Site injection soreness, fatigue; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A 60-years-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN8730) dose 1 via an unspecified route of administration, administered in arm Left on 29Mar2021 02:00 as single dose for covid-19 immunisation. Medical history included blood cholesterol increased. Concomitant medications included simvastatin (SIMVASTATIN), ergocalciferol (CALCIFEROL VIT D), omega-3 (OMEGA-3 NOS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. She experienced site injection soreness and fatigue. The patient did not receive treatment for the events. The outcome of the events were recovered. No follow-up attempts are needed. No further information is expected.

Three hours after receiving the 2nd dose, right arm begin to ache. Felt ache down the arm into the hand and fingers. Body aches and chills through out the night ache across the shoulders, neck and up toward the base of the neck and lower back. Next day symptoms were slightly worse I developed a slight headache became very listless had to go to bed. Friday night, the injection site arm developed a red rash that was warm to the touch.

After vaccine administration in the right deltoid muscle, patient's arm swelled at the injection site. Patient was given one dose of 25mg Benadryl as a precaution.

Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine with tingling on shoulder blade, then red rash, then painful blisters; stinging/stabbing pain; inability to sleep due to discomfort Lymphadenopathy-swelling in my left breast and chest; much discomfort

Small lesion appeared under right shoulder blade on back, thought it was a bite and put triple antibiotic cream on it, radiating pain through right breast - took 200mg Advil every 6 hours for 3-4 days. Made dr appt after a photo taken looked to me like shingles. Dr diagnosed herpes/varcella zoster. No further treatment.

I experienced the known, Headache, body/joint pain, injection site pain....what followed was severe abdominal pain followed by frequent diarrhea & high levels of gas. This started approx 10 hours after my second injection(on Wed 4/14/21)and lasted until midday 4 days (Sunday 4/18/21). I did not run a temperature. After waiting for it to go away (48 hours), I called COVID-19 line and they said to go to BRAT diet. I did that & added Pedialyte to replenish electrolytes & help with the extreme fatigue(over and above my usual MS fatigue). I also treated the extreme gas with gas-x chewable tablets. The diarrhea was like prepping for a colonoscopy, nothing stayed in my system & the stools were very loose & yellow in color.

Dose 1: Redness, swelling at injection site, Headache, dizzy, nauseous, fever over 100 degrees F. Everyday or every other day. Diarrhea, muscle aches, joint aches, neck pain, fatigue all lasting 2-3 weeks. Still had 100 degree fever the night before Dose 2. Told nurses at Super Station about all the side effects from first dose and they had me take a Benadryl before 2nd shot, stay 30 min. for observation, then they told me to take Tylenol when I got home, which I did. Taking 2-3 more over the next day or so. Did not get redness or swelling at shot site, did have headache, fever, fatigue, muscle and joint pain, but much more muted than with the first dose with no medication. I continue to have a fever of 100 degrees about every 2-3 days. Some days I have diarrhea or feel headachy and have to be in bed most of the day. Usually fever is first symptom on those days. It's been 3 weeks since last dose and my fever was 100 yesterday and spent 15 hours in bed.

Redness to face/arms, Itching to body Shortness of breath, Feeling it move to my mouth, throat, nose, so far some symptoms have lasted 3 days

On Sunday I felt a little achy and after working from 12 -4 pm came home and went to bed because I had the chills. I know I had taken my temperature around 10 am and it was 100.1 degrees. After I went to bed I know my fever escalated, but I didn't check it again, thinking it was just the reaction to the shot. I did take some Ibuprofen, too. Monday I felt fine. On Tuesday 4/20/21, I noticed after my shower a rash on my neck and chest area. I have been taking a Women's One A Day vitamin for about a week, but that is the only thing other than the Ibuprofen I have taken. I will call my Dr to report as well.

Right facial/injection site numbness Vital Signs: BP 150/100 HR 76 (84) Resp 20 O2Sat 98 Skin Signs: Clammy, diaphoretic Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Observation, patient remained AOx4. Assessed/evaluation by Doctor. 12:10 PM Vital Signs: BP 138/90 HR 74 Resp 20 O2Sat 93 Skin Signs: Clammy (mild), Diaphoretic Circulation: Cap refill <2sec Follow up Treatment: Patient states numbness in face has lessened in severity Notes: Encouraged patient to continue hydration at home Disposition: Home with friend

Adverse effect of vaccine, initial encounter Rash - Notes that rash started after she received the second COVID dose but unable to state exactly when the rash started - Vaccine received in left arm and has a rash to left upper arm and chest - + redness - Denies fever, chills, itchingPlan: - Likely related to recent COVID vaccine - Will have clinic RN submit VAERS report - Recommend a moisturizer - Pt will continue to monitor for worsening symptoms - Follow-up with PCP as needed for concerns

I really don't know if this is at all related to the second vaccination but we were encouraged to report any odd experience. About 27 hours after receiving the second shot, what appears to be a menstrual cycle began. I last had my period in 2015. For additional context, I have a history of fibroids and still have a good sized one. In late February I had a spotting issue but what I'm experiencing now is a full on period. I was already in contact with my PCP and an OB/GYN for testing related to the Feb. spotting event and as a result of that will be having an endometrial biopsy and hysteroscopy. Outside of the above, I had a sore arm and bruising at the injection site. Thank you

Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient reported significant swelling and a 4 inch raised hive at injection site. Patient took Benadryl and it went down and resolved after a few days. Reaction started on day 8 after injection.

Patient reported that she had itching and hives 24 hours after receiving 1st dose of Covid vaccine. Pt. reports taking benadryl and hives going away after unspecified time.

Red rash mostly under right eye, but small place under left eye as well. Does not hurt or itch, just swollen and red. Also developed a fever blister/cold sore on upper lip at the same time. It's been about 23 days since first shot and I still have the rash under my right eye, but cold sore is gone. Did not see doctor. Treated cold sore with Blistex and just put vaseline on rash at night.

1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs. 2) Sharp breast pain, on the left breast,

Developed fatigue and nausea two days after vaccine. Began to have skin irritation the same day. Developed a rash five days after vaccine and was diagnosed with shingles six days after vaccination. Took Enbrel and methotrexate two days after vaccination.

On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the night of 4/11/21 (9:00pm) fever returned. I took advil and went to sleep. On 4/12/21 I woke up with my arm very swollen and it was hot to touch. By the afternoon I was worse and the area was turning red so I went to the Urgent care and diagnosed with Cellulitis (which I have never had and didn't understand at first what this was about). I was treated and returned to my regular Doctor for follow up. I still have this thing and although it's better it's not gone as of this report and it is causing me distress in typing, cleaning and so on.

Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Severe, Error: Incorrect Reconstitution

Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree fever, feeling unwell, no appetite (but not nauseous) X 1-1/2 days Sore arm/difficulty raising arm X several days; tolerable

post vaccine pt was noted to have a light rash on upper extremities, c/o of tightness in chest. Pt offered Benadryl and refused as pt had a full schedule planned today. Pt expressed that she was feeling well enough to leave on her own. Pt was released at 10:47 am vital as follows: 1032 BP 136/89 HR 94 RR 20 SpO2 97% 1040 BP 137/91 HR 92 RR 20 SpO2 98% 1045 BP 138/90 HR 83 RR 18 SpO2 99%

At time of injection- immediate warm sensation in stomach, neck and face. Slight flush color in face. Itching in face and forehead however NO signs of hives or labored breathing. Intake if fluids. No Benadryl or Epi-pen required. Symptoms diminished and left facility in 10-15 minutes. 2-3 hours later- body aches, mild nausea and mild headache. NO Tylenol 1 am- woke from sleep- Headache . Took 2 Tylenol. Went to sleep. Woke at 6 am- string body aches, nausea, and very sore arm. NO headache. Took Tylenol. Stated in bed with fluids until 2 pm. Little appetite. Slight headache in evening. Achey feeling subsided . Next day - Mild body aches and nausea. Took one Tylenol. No appetite.

Individual arrived to post vaccine area moments after COVID 19 Pfizer vaccine dose 1. Individual noted some redness itching and hives to the forehead, neck, and arms bilaterally. Individual denied difficulty breathing, denied tongue lip or throat swelling. Individual had no issues handling saliva, no stridor/objective shortness of breath. Vital signs: 153/90 HR 71, O2 100% taken by post vaccine nurse. Individual given 25mg PO Benadryl at 11:20, monitored by post vaccine nurse until 12:40. At 12:35 symptoms resolved. Escorted by sister, instructed/agreed not to drive.

Day after shot (Saturday 10 April) - nausea, headache, 101.5 fever, body aches, arm soreness, tiredness 2nd day after shot (Sunday 11 April) - slight headache, tiredness, red rash around injection site and itching. My arm was also swollen and more sensitive to touch than movement. The itching wasn't bad enough that I needed to take any meds. I just wanted to report this adverse reaction to the second shot.

On 3/15/2021 my neck and scalp began to itch/hurt. . On 3/18/2021 my scalp broke out in rash consisting of blisters that wept and formed crusts. On 3/19/2021 I was diagnosed with shingles and started on an anti-viral medication and gabapentin.

Systemic: Allergic: Itch Generalized-Medium, Additional Details: Administered second dose on right arm. Client reported no reaction after first dose except for sore arm. No history of allergies or adverse reactions from vaccine. Reported generalized itchiness. Gave 50 mg Benadryl. Client's husband drove her here and back home. First dose of vitals: 97.7 degrees F, 82 bpm, 98% O2, 130/94 BP, RR 16 at 1756. Second dose of vitals taken 1815: 72 bpm, 98% O2, 97 degrees F, BP 120/80. Client left approx. 1830 reports decreased generalized itchiness.

Shingles/rash/bites or something around mid section where shingles would normally appear. Link I found on line was for rare reaction in women.

Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.

Local Reaction o hives, itchy, red R arm/L arm Systemic Reaction o neck, scalp, stomach, arms: hives, itchy; runny nose, scratchy throat Pt reported reaction started just under 2 hrs post covid vaccine, and had not resolved at time of call 3.5 hours later

Swelling lower left arm and hand. Intensified to include entire left arm. Deep bruised ache feeling. Heaviness. Could not fit arm through sleeve. Became difficult to use hand due to swelling. Due to swelling now have carpal tunnel in left hand with numbness & painful tingling.

Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) lump in my throat; turned red on my face and neck and chest and arms; when I get nervous; between my eyes on my forehead felt like a round circle (no bump) (past the bridge above eyebrows). It didn't hurt, but I felt something; felt odd; felt like my eyes were moving back and forth; very very cold; hands were ice cold; This is a spontaneous report received a contactable consumer, the patient. A 60-year-old adult female received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 14Mar2021 (at 60-years-old), for COVID-19 immunisation. Relevant medical history included high blood pressure, and diabetes. There were no concomitant medications or past drug history reported. The patient reported that she had a couple of reactions the first day, so she was afraid to take the second one. The patient stated that within eight minutes she had a lump in her throat, which she gets when she is nervous and was unsure if from shot or nervousness. The patient reported that then she turned red on her face, neck, chest, and arms. The patient reported that the redness lasted about six or seven hours and did not bother her at all. The patient explained that then between her eyes on her forehead felt like a round circle (no bump) past the bridge above eyebrows. The patient stated that it did not hurt but felt like something. The patient also stated that she felt like she was going to get headache, though did not. The patient reported that it just felt odd. The patient also stated that she felt like her eyes were moving back and forth. Though when she looked in the mirror, they were fine. The patient stated that the eyes happened three times but by the time she looked in the mirror they looked fine. The patient added that she never felt sick or anything though about six or eight hours later she got very very cold which only lasted about a minute. The patient stated that her hands were ice cold and then it all went back to normal. The outcome of the events turned red on my face and neck and chest and arms was recovered on an unspecified date in Mar2021 after 6-7 hours. The outcome of the event she got very very cold was recovered on an unspecified date in Mar2021 after one minute. The outcome of the events hands were ice cold, and felt like my eyes were moving back and forth was recovered on an unspecified date in Mar2021. The outcome of the events, lump in my throat, get nervous, between my eyes on my forehead felt like a round circle (no bump), felt something, and felt odd, was unknown. Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Fever, chills, muscle aches, malaise, site pain extending down arm and into shoulder, headache, nausea. Adverse events lasted 2 days. Treated with tylenol.

Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient complained of redness, some swelling, and itchyness,and a rash at the site of injection and that was on the chest as well that lasted about 14 days and she treated it with hydrocortisone cream

Four days after I felt a sore area on my shoulder. Next morning I had a rash on my shoulder and down my arm. The worst areas were my shoulder and inside elbow. It was like a burn. Felt and looked like a motorcycle muffler burn I once had. I waited it out and it began to hurt less and itch. After 6 days it is only a pink area where it was broke out.

04/26/21 @ 1324 Patient c/o itching at injection site right arm. Upon assessment, there was no redness, swelling, Skin Temp WNL, no skin discoloration at the injection site. VS 97% O2, 87HR, BP: 190/98. 1330 - Benadryl was administered 50 mg tab by mouth. 1345- Patient states, "I feel better, I no longer have itching on my arm".

pt was waiting in the waiting area , after 5 minutes patient started itching and had pink skin due to rash

Patient complained of vaccine site feeling burning & on fire. area red, scattered red raised macula rash with itching on upper arm and axilla at 4:40pm. Cetirizine 10mg oral given, ice pack applied at 4:45pm. Redness and burning improved at 5:10. No signs of respiratory distress or signs of anaphylaxis. Reported to physician. Patient to take Cetirizine for next few days. Ambulated to car without any incident, daughter driving.

Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.

Hives - on thighs, belly, lower back, rear of arms. I've had hives previously and these progressed as I've experienced before. Treated with OTC antihistamines and aleve for 1 week, then video visit with PCP. Prescribed Montekulast 1 per day, and hives improved within 24 hours and continually improved until gone as of today April 27 - approx 2 weeks after symptoms started.

I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck. Went to dr rash not there. Treated for shingles. Rash reappeared later that evening. Husband received vaccine same date/time. Being Treated for shingles. He reported his event

I got one papulovesicle on my left side of back with a little itching at first day and became seven papulovesicles today with the paint the left side of breast. I had suffered Herpes zoster 20 years ago. I thought this symptoms might be reactivation of Zoster.

After the first dose, developed a skin rash behind the knee. With the second dose I have a skin rash in multiple places and an inflamed lymph gland under my right arm.

1) Slight redness in neck/chest area approx. 75 mins after shot 2) Tingling, pins&needles on both sides of face between jaw and cheekbones approx 90 minutes after shot that lasted for about 10-15 minutes. This was followed by numbness around cheekbone area that gradually went away by 4/29/2021 Emergency room doctor gave me antihistamine and I took antihistamine 6 hours later before bedtime and twice the following day. I also used a coldpack on my face. 3) Two days after shot 4/29/2021, slight numbness at tip of my little finger on right hand started in the morning.

1/11/2021: Within 40 minutes of receiving 2nd dose Pfizer vaccine, began having tingling bilateral arms proximal & distal. Following day, developed a temperature to 102F which remained x4 days. Since this time, has had continued tingling of the arms & low grade temperature (99F) & has begun having weakness of her upper extremities only with hypersensitivity to heat, as well as touch, but interestingly having decreased sensation to touch of her fingers, feeling as though she wears gloves, with no weakness anywhere else on her body. She has also beginning to develop a sense of decrease cognition. She has been seen by Neurology who felt this was a neurologic hypersensitivity reaction. Initially when she began having complaints following injections/day 1, she was given Benadryl with no improvement beyond causing her to sleep. Since this time she has also been placed on prednisone with no interval improvement. Relates no cutaneous lesions beyond mottling of her arms/no frank urticaria dermatitis etc., and has had no GI complaints or cardiovascular sequela. 4/19/21: This 60 y.o., female is referred by MD for evaluation of bilateral hand pain, weakness and numbness starting shortly after the 2nd dose of her COVID vaccine (5 her). The patient has generally been in excellent health. On Monday, January 11th at 9:20 a.m. she received the 2nd dose of COVID vaccine (Pfizer), in the left deltoid. She had no immediate reaction but while driving about 45 min later developed numbness and tingling bilaterally in her face, lips, tongue and hands. She awakened at about 3:00 a.m. with fever of 102, no abnormal sensations in her face but pain, redness and sensitivity in both hands. Systemic symptoms resolved in several days. Hand symptoms have continued to date. Pain can range as high as 8/10. She has marked sensitivity such that if she or someone else touches her hands it is extremely painful. She sleeps with opera gloves to protect them. She has not had neck pain but has developed grip weakness and has to use 2 hands to hold a cup of coffee. She has never had adverse reactions to vaccines in the past. She has had no immunologic disorders. She initially saw Dr. who tried a short course of steroids without benefit. She took gabapentin 200 mg followed by 100 and slept for hours without a change in the pain. NSAIDs have been ineffective. No other medications have been tried. She has had nothing to suggest a symptomatic COVID infection. 4/23/21: The patient continues to have bilateral hand sensitivity and temperature lability. The EMG showed diffusely slow sensory conductions, consistent with the non correctable low temperature of her hands. Motor conductions were notable for slowing in the right median motor with drop in amplitude proximally but with waveforms that did not suggest conduction block. All motor terminal latencies and F response latencies were normal. Overall the study is probably normal within technical limitations but if necessary should be repeated in about a month with her hands warmer. The nortriptyline was just approved yesterday and the blood tests 2 days ago. She will start the nortriptyline over the weekend and let me know if it is tolerable or effective. She will get the blood work done early next week and I will review the results with her. HISTORY: This patient with bilateral hand dysesthesias and temperature lability following COVID vaccination comes in for neurophysiologic testing. Notably the nortriptyline was just approved and she has not yet started taking it. Similar the blood test were just approved 2 days ago and she will have them drawn next week. Her symptoms have not changed since he was here last.

Symptoms: Skin rash (exanthema) initially appeared on left arm on 4/27 (4th day after vaccination) and extended to upper back over the following 1 -2 days. Eventually the skin rash appeared over both left and right arms as well as full back. No pain but itchy. Syptom still persists as of today (4/29) Hemorrhoid broke and blood came out (4/29). Time course: 4 - 5 days

Pt mentioned to the vaccinator that she had developed hives after her first shot that she received on 3/2/2021. She complained of itchiness and hives and had to take benadryl for 2 days until they were gone. PT stayed at recovery area for 30 minutes to monitor for any anaphylactic response. She left without further issues. Contact information given to Pt in case anything develops later today.

Onset of pruritic maculopapular rash on trunk that spread to neck 55 hours after vaccination. Responded to treatment with H1 and H2 blockers. No steroids required. No anaphylaxis noted.

60 yo female received her first pfizer vaccine on 3/20/21; she tested positive for Covid on 4/1/21 and took tylenol and motrin for her symptoms. She broke out with a rash on her right lower back on 4/6/21 that spread to her left lower back after one day and then moved to her chest. She was concerned that she had a shingles outbreak. (of note, she had a shingles vaccine in Fall 2020). She reports she did not have a medical evaluation to determine the diagnosis of this rash. She did not put anything on the rash. The rash lasted approximately 5 days and resolved spontaneously. She has not symptoms now and was calling to ask if she could get her second vaccine.

Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.

Rash; This is a spontaneous report from a non-contactable consumer (Patient) via Medical Information Team. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 15Apr2021 (at the age of 60-years), as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient took 1st dose of COVID-19 VACCINE. On 16Apr2021 (one day after vaccination), patient had rash. Patient wanted to know if she can take Benadryl for the rash. Patient stated that she received documentation that this normally happened within an hour, and now this reaction occurred one day later and was asking about any information on side effects. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

1/7/2021 vaccination 1/8/2021 bruise/pain R lower leg, hard warm to touch. Painful and sore. Progressively got worse; red, bluer. 1/10 or 1/11 ER . Ultra sound on leg. 10cm clot. Put me on aspirin, warm compresses. Had to increase aspirin up to 2x day. It eventually cleared. Referred to surgeon. Found some other veins their inspecting further. *have not had any more clots

Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.

started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.

April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark urine Jaundice went to urgent care, they advised i go to ER as they felt i needed an abdominal scan to see why i had so much bilirubin in my urine. Went to Hospital. CBC showed my hemoglobin was 5.9. Went down to 4.9 before first transfusionhad CT SCan and sonogram.. Was admitted and disagnosed with hemolytic Anemia brought on by Covid Vaccine. had 5 blood transfusions over the course of my 8 day hospital stay. As of 5/06/21 My hemogloblin is 10.3 and has been at this level for past three weeks, I am currently under the care of a hemotologist

Shingles - intense internal left abdominal and side pain, followed by skin rash on left side a week later. Treated with pain medication, and anti-virus medication. Still experiencing some pain and some rash 2 months later, at the time of this report. Currently continuing pain medication.

Arm pain at site of injection; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:30 (Lot Number: EL9269, Expiration date: unknown, at the age of 60-years-old) as first dose, single dose for covid-19 immunisation. Medical history included ongoing hypothyroid. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and supplements (vitamins). No covid prior vaccination. Covid not tested post vaccination. The patient experienced arm pain at site of injection on 23Feb2021 20:30. No treatment was received. The outcome of the event was not recovered.

severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), dose 2 via an unspecified route of administration, administered in arm left on 22Apr2021 12:30 as 2nd dose, single for covid-19 immunisation. Medical history included fibromyalgia, ongoing diabetes type2, non-Alcoholic Cirrhosis, ongoing Chronic fatigue syndrome (CFS), spinal degeneration, hypo thyroid, gallbladder removal, hernia repair, hysterectomy, restless leg syndrome, sleep apnea, Known allergies with Wellbutrin, Naltrexone, tape. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) administered in arm left on 23Mar2021 12:30 for COVID-19 Immunization. The patient reported to ER with severe swelling of lips and tongue, severe itching and rash on 30Apr2021 09:15. The adverse event result in emergency room/department or urgent care. The patient received treatment (IV of Solumedrol and Benedryl) for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination with Nasal swab and result was negative. The outcome of the events was resolved with sequelae.

starting 1st day of injection pain at injection site and radiating up to shoulder with swelling around the site area. Nausea . starting days 2 & 3 pains increased up further on left side of the arm to neck (left side only) , switched from taking Ibuprofen 800mg throughout the day after day 3 - 4 body aches and pains in left leg/thigh muscles , switched to Tylenol 1000mg everyday from day 1 rubbing down multiple time daily with rubbing alcohol , nightly alcohol with Epsom bath soaks. pains for about 2 weeks before relief. May 11 no pain just still tiredness . Yesterday and today believe all resolved .

Anaphylaxis (lip swelling, generalized hives, shortness of breath) within 30-45 minutes of vaccine. Because patient has a history of anaphylaxis, she was able to treat it by giving herself epinephrine, oral antihistamines, and nebulizer treatment with levalbuterol every few hours for the next 3 days. She recovered and did not report this until 5/12/21.

severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Mar2021 10:30 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient medical history was not reported. Concomitant medications included chlorthalidone; diltiazem; doxepin; famotidine (PEPCID AC); fexofenadine hydrochloride (ALLEGRA). The patient experienced severe systemic itching, facial swelling, hives on back, flushing on chest, face, arms, hands on 18Mar2021 10:45. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment received for the adverse events included diphenhydramine (BENADRYL) and steroids. The outcome of events was recovered in 2021. Information on the batch number has been requested.

hives; This is a spontaneous report from a contactable physician via Pfizer sponsored program. A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation Solution for injection, Lot Number unknown, Expiry date: 31Jul2021) via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Apr2021 patient Stated that hives experienced almost immediately after receiving the first dose Pfizer Covid Vaccine. Outcome of the event was recovered. Follow-up attempts are needed. Further information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, urticaria cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.

After 1 shot had doctor appt and was notice that my kidneys function has declined slightly, then 7 days after the second shot I notice these blisters on my right lower leg near ankle filled with clear liquid it was a rash of multiple blisters. After about 7days they begin to go down I did not try to pop them I just took pictures each day and now they have went down today is May 19th 2021. and the area has dark scabs that seem to be going away.

Rash on face; Rash on neck; swollen tongue; swollen lips; swollen face; itchy hands/Itchy; Lip tingling; Swelling of the arms; swelling and tingling; swelling and tingling; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient) reported that a 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206, Expiry Date of Covid-19 Vaccine: Unknown), via an unspecified route of administration on 05Mar2021 03:00 PM in the left arm at 1st dose, single for COVID-19 immunisation. The patient age at vaccination was 60 Years. Medical history included vertigo, migraines, Sjogren's syndrome (diagnosed about 10 year ago), thyroid cancer, diabetes and high blood pressure. known allergies included Latex, daptomycin, ceftaroline fosamil, doxcycline, fremanezumab-vfrm. The patient had second shingles shot with Shingrex and she got a few chicken pox rash around the shot itself but that's pretty normal, the onset age was 58 years and at the age of 60 years old at the time of the last flu vaccine, and has received multiple flu shots in the past with unknown brand of flu vaccine. On 05Mar2021 03:15 PM, the patient experienced rash on face, rash on neck, swollen tongue, swollen lips, swollen face, itchy hands/Itchy, lip tingling, swelling of the arms and swelling and tingling. The report received as, on 05Mar2021, received her first Pfizer Covid vaccine dose. 10 minutes later patient had an allergic reaction which included swelling of her lips and tongue, rash on her body, and swollen and itchy hands. The patient reported a second reaction on 07Mar2021, which were the same symptoms as the first and then another (3rd) reaction on 12Mar2021. She has been to the ER 3 times and was prescribed oral steroids and was given a steroid injection each time. She feels that each time the steroid injection wears off, the symptoms return. She wants to know how long this side effect could last. The patient had allergic reactions to it and patient as now had three allergic reactions to it and was wondering have you had other people that have had multiple allergic reactions if the steroid they were given has run out. The patient was given Decadron on day 1 and it ran out in a couple of days because it's a short-acting steroid, then they gave her the longer-acting five-day steroid, betamethasone, patient was taking oral, but it's not as good as the beta methasone shot, patient was asking to have we had other people who have needed more steroids even though the shots have stayed in their system. She wants to know if she is going to have more allergic reactions down the road as the steroids' run out. The patient had three injectable rounds of steroid shots on 05Mar2021, 07Mar2021, and 12Mar2021 and had two courses of oral steroids on 05Mar2021 and 12Mar2021. The patient said 10 to 15 minutes after receiving the shot, had lip swelling and tingling, rash on face, then within a half hour started to swell up. The patient stated that at the center where she got her vaccination, they gave her Benadryl but noticed her symptoms getting worse, packed her up in an ambulance to hospital, and there they gave her Decadron and Pepcid and more Benadryl. The patient states it wasn't anaphylaxis but was an allergic reaction. This was on 05Mar2021, right after getting the shot. It is explained the events improved when given the medications at the ER. She still gets a little itchy once in a while but she is on oral steriods and 50 mg of Benadryl every day. This is her third injectable and second round or oral steriods. Caller has not NDC, Lot, or Expiry for those product as they are from the pharmacy. She also has no NDC, Lot, or Expiry for the Benadryl being used, it is also from the pharmacy. The patient informed as, this was her first Covid vaccination and she was not getting the second one. The patient husband and daughter have had their Covid vaccines and had no reactions at all. The patient was not had covid prior and post vaccination. The patient was not received other vaccine in four weeks. Abd received many daily prescriptions and supplements medications in two weeks. Adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and treated with Benedryl, Steroids, Pepcid. Outcome of the events itchy hands/Itchy, swelling of the arms, swelling and tingling was unknown, for remaining events outcome was recovering. Follow-up attempts are required. Further information was expected.

Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation. Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago. No follow-up attempts are needed. No further information is expected.

about 1+ hours ago, she came down with a massive headache; it as a "bright, red, rashy and blotchy"/her (left) arm was bright red with a (blotchy) rash (across her left arm); it was "hot as hell"/her (left) arm was hot as hell; She had a blotchy rash across her left arm; She had injection site soreness for 3 days after receiving her first COVID-19 Vaccine; couldn't move her arm at all; left arm was a little tender to move; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 27Apr2021 (lot number: EW0171) at single dose for COVID-19 immunization. The relevant medical history included ongoing multiple allergies, ongoing peanut allergy, ongoing reaction to sulfites (sulfites in wine gave her a headache), ongoing reaction to preservatives (She said she would become anxious & then turn bright red & become short of breath. She said sometimes her tongue would turn pale & white looking & she would faint. She said she carried Benadryl with her & the Benadryl took care of her reactions. She said Benadryl had been her "MO" for treating reactions. She said the doctors don't want to give her an EpiPen unless her reaction is a documented as an anaphylactic reaction) and sensitive to the epinephrine (used in dental treatments caused her to become short of breath, and faint). Concomitant medications included potassium acetate from Apr2021 and ongoing for an unspecified indication. The patient previously took Benadryl from unspecified date to treat her peanut allergy and won't help her allergic reaction to peanuts; also took Benadryl from unspecified date for reaction to preservatives. The patient said that 8 days after the injection, she experienced a massive headache and the left arm where she received the vaccine had a red "circle" around the injection site. She described it as a "bright, red, rashy and blotchy" and said it was "hot as hell". She explained her son and husband were vaccinated right after her, by the same person, and they didn't develop anything. She explained she thought her reaction was due to the preservative in the vaccine as she had a lot of allergies. She expressed her concern about potentially developing anaphylaxis to the second dose of the vaccine after her reaction to the first. She asked for the risk associated with taking the second dose of the vaccine after such reaction to the first. The nurse furtherly reported that about 1+ hours prior to the report (clarified as the time of the report, 06May2021), she came down with a massive headache. She said her husband brought her home something for her headache. She said her (left) arm was bright red with a (blotchy) rash (across her left arm). She said her (left) arm was hot as hell. Reported she had a hesitation to take the COVID-19 Vaccine because she had a lot of allergies to begin with, but nothing that caused an anaphylactic reaction. On 27Apr2021, she had injection site soreness for 3 days after receiving her first COVID-19 Vaccine and her left arm was a little tender to move at that time, but not as bad as after receiving a TB (vaccine) shot. She said after the TB vaccine shot, she couldn't move her arm at all. She reported her symptoms came out of nowhere, and she believed her headache and left arm rash were directly related to the COVID-19 Vaccine. She said her son and husband went immediately after her for their COVID-19 Vaccines, and had the same exact person administer the COVID-19 Vaccine. She said neither her son, nor husband, had a reaction from the COVID-19 Vaccine. No further details provided. The events did not require a visit to Emergency Room or Physician Office. Treatment for headache included 1 Extra Strength Tylenol 500mg caplet. Treatment for left arm blotchy rash included a cold compress on her left arm. She said she also took Benadryl (clarified as Walgreens Children's Dye Free liquid "Wal-Dryl" Diphenhydramine). She said she preferred to use the children's liquid Diphenhydramine because when she had a reaction, sometimes her throat felt like it was swelling. The outcome of the event left arm was a little tender to move and couldn't move her arm at all were recovered on an unspecified date, for event injection site soreness for 3 days after receiving her first COVID-19 Vaccine was recovered in Apr2021, while the other events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events headache, Vaccination site erythema, Vaccination site warmth, and Vaccination site rash and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; Severe allergic reaction; I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; My body was red and I had blotches bumps all over me my back under my right breast; My body was red and I had blotches bumps all over me my back under my right breast; My entire body was inflamed; Started getting hives on my back, under my right breast, both arms and both legs and thighs and I started getting bump. I broke out in hives in sleep in middle of night; I woke up out of my sleep in the middle of the night like the wee hours of the morning itching; I had like difficulty breathing; I had severe headache and I had it like all week; severe headache; My pressure went up like 140 over 100; high blood pressure; This is spontaneous report from a contactable consumer (Patient herself). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unknown route route on 04May2021, as a single dose, for COVID-19 immunization. Patient's medical history included seasonal allergy (using an inhaler), Asthma and Diabetes. The patient's concomitant medications included insulin. On the same day of vaccination on 04May2021, at the first hour, the patient had a severe allergic reaction. The patient also experienced severe headache and I had it like all week and her pressure went up like 140 over 100 and then like the next day you know I had like difficulty breathing. On the third day, The patient also had a severe allergic reaction. The patient stated that her entire body was inflamed and then she started getting hives on her back, under the right breast, both arms and both legs and thighs. The patient also experienced bumps. The patient further stated that she had dizziness and was going to pass out when she had to walk down the stairs. The patient also stated that she broke out in to hives in her sleep in the middle of the night. The patient had itching at the wee hours in the morning. The patient stated that she went and looked in the mirror and her body was red and I had blotches bumps all over her back under my right breast. The patient wanted to know whether she can take the second shot. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The patient did not had any physician visit for the events. The patient used Benadryl as treatment medication for the events. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The outcome of the events was unknown. Information about batch/lot number was available. Further information was expected.

Swollen injection site, red itchy, hard, painful. Whole arm pain. Tylenol and also Benadryl at night.

Pt reported itching all over the body about 5-10mins after the vaccine. I gave her 25mg of Diphenhydramine solution by mouth immediately and asked her to monitor the symptoms and let us know. She mentioned she has Lupus and is not on any drugs for it right now. Other pharmacist called her Dr and the patient herself called Dr to report the reaction. Dr sent a prescription for Prednisone 10mg and she took 2 tabs right away.

Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 210/103, dizziness, and shaky. Epinephrine given with relief of swelling within 20 min. Two hours later reports vomiting and diarrhea.

tiredness; headache; muscle pain; feeling unwell; swollen lymph nodes; hives with pain in them; pain; I got Shingles; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 03Mar2021 13:15 (also reported 15Mar2021 13:30) (Batch/Lot Number: ENG198) (at the age of 60 years old) as 1st dose, single for COVID-19 immunisation. Medical history included stage 3 kidney disease and thyroid disorder. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was in doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had other medications received within 2 weeks of vaccination (unspecified). On 03Mar2021, the patient experienced tiredness, headache, muscle pain, feeling unwell, swollen lymph nodes, hives with pain in them, pain and she got shingles. The events resulted in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included Valtrex, anti biotic and creme. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event shingles was unknown; and not recovered outcome for the other events. No follow-up attempts are needed. No further information is expected.

Injection site pain; Nausea; Fever (unknown temperature); Chills; Body aches; Bad headache; This is spontaneous report from contactable consumer, the patient. A 60-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 2, via an unspecified route of administration in the right arm on 15Mar2021 at 01:00 PM, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, whether the patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination the patient was not tested for COVID-19. The patient had no current illness. Past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 1 via an unspecified route of administration in the right arm on 22Feb2021 at 01:15 PM, as a single dose for COVID-19 immunisation. Medical history included allergy to ibuprofen and breast cancer. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), 81 mg aspirin (MANUFACTURER UNKNOWN) all for unknown indication. On 15Mar2021 at 01:00 PM, the patient experienced bad headache, body aches, fever (unknown temperature), chills, nausea and injection site pain. The injection site pain was minimized. No therapeutic measures were taken for the events. The clinical outcome of bad headache, body aches, fever (unknown temperature), chills and nausea were unknown. The clinical outcome of injection site pain was resolving. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.

It's like eczema in skin/patches like an eczema; Itchy; little blots of red; Allergic reaction; Pain Whole Left arm; Headaches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Deltoid Left on 03Apr2021 12:00 (Lot Number: EN6198) as 1st dose, single, and via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 12:00 (Lot Number: ER8737) as 2nd dose, single for COVID-19 immunization. Medical history included Crohn's disease and immunodeficiency from an unknown date. The patient is not on other medication and doesn't take anything. On 04Apr2021, the next day after vaccination of the first dose, the patient had pain whole left arm and headaches and took Tylenol. On 05Apr2021, patient experienced it's like eczema in skin/patches like an eczema, little blots of red, that is really itchy, and allergic reaction. The patient took an antihistamine. On 25Apr2021, after the second dose, the patient again had pain whole left arm and headaches and on an unspecified date after the second dose had the same patches like an eczema not clearing still itching. Patient was still taking antihistamine. No emergency room and physician's office visit was done. The outcome of the events was not recovered.

Exhaustion; Red itchy arm; Red itchy arm; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-Sponsored Patient Support Program. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6201), via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included allergies (had a reaction to a lot of things in life), headaches since she was about 12 years old, supraventricular tachycardia, cardiac loop which died, normally had abnormally low blood pressure her whole life (normally 98 would be high and 58-60 as the bottom number would be normal). Concomitant medications were not reported. On 12Mar2021, the patient experienced red itchy arm. After the vaccination, she was told to sit in the sitting area because she had an unspecified underlying condition and had a reaction to a lot of things in life, just allergies basically. The patient's arm was red. Within a couple minutes and all of a sudden, she had streaks down it and it started getting very itchy. The red, itchy arm lasted about half an hour. On 13Mar2021, the patient experienced heavy duty exhaustion for a week - she thought she was just tired from stress. The clinical outcome of "red itchy arm" was resolved on 12Mar2021, of exhaustion was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021539682 same patient, different dose number and event

allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.

developed cellulitis with right breast. I am 2 years post radiation for right breast cancer. No trauma has occurred this year to right breast. Area of radiation of right breast became red hot weeping with an unknown abscess that developed internally in the area of right breast where cancer was. This area was treated with 2 round of antibiotics with out being fully cleared up. New area of redness has developed again in the right breast yesterday 5/26/21. Another round of antibiotics will be started today. The only introduction of anything placed on body or skin is the vaccine.

Pt had first COVID19 vaccine at Pharmacy on 5/25/2021. It was Pfizer vaccine. Pt came in to see me on 5/26/2021 with blisters on right great toe, right 2nd toe. Painful only secondary to wearing shoes. Pt has good pulses and trace edema bilaterally which is normal for her. Pt reports the blister on her right great toe appeared on 5/26/2021 and the blister on right 2nd toe appeared on 5/27/2021

headache; severe rashes in my forehead; bumps puffy face; swollen lymphnodes on the right side; sensitive to touch itching, and burning; sensitive to touch itching, and burning; This is a spontaneous report from a contactable other hcp (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6201), dose 1 intramuscular, administered in Arm Right on 11Feb2021 at 10:30 (at the age of 60 years old) as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, mild hypertension, acid reflux from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was allergic to aspirin, NSAID, shellfish and some other fish. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM); metoprolol tartrate (METOPROLOL TARTRATE); omeprazole (OMEPRAZOLE); levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. On 25Feb2021, 15 days after the first dose she got a headache, severe rashes in my forehead, bumps puffy face, swollen lymph nodes on the right side only sensitive to touch itching, and burning. The symptoms are beginning to subside now but was scheduled to get her 2nd dose on March 4th. She would like some guidance. The patient was treated with antibiotics. The patient visited physician office due to events. The outcome of the events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; This is a spontaneous report from a contactable consumer(patient). This 60-year-old (non pregnant) female Patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown), via an unspecified route of administration in the left arm, on 26Jan2021 at 08:00 (at the age of 60-year-old), as single dose, for COVID-19 immunization, in the hospital. Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Patient had no other known illnesses. The first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number EK5730, Expiration date was not reported), received via an unspecified route of administration, administered in left arm on 05Jan2021 at 13:00 for COVID-19 immunization. Concomitant medication was not reported. Prior the vaccination, was not diagnosis with COVID-19.post vaccination, no COVID test was performed. On 29Jan2021 at 6:00, patient experienced Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 postinjection. No treatment was received for the events. The outcome of the events was reported as not recovered. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

aching all over; her arm hurt very bad where she got shot, right arm, "her arm was killing her; shooting from her arm up to her neck; chills; feeling really unwell; heart started beating a little bit fast; shortness of breath; tiredness; headache; muscle pain; joint pain really bad; really weak; Back Pain; Throat Hurting; injection site pain; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the right arm on 12May2021 08:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history included allergic to dye (last time she had black dye, her head was itching and burning like fire and her head is still red and her hair is falling out by handfuls), back injury ongoing since 2004, and ongoing diabetes mellitus that started 14.5 years ago. The patient was tested negative on the COVID Nasal swab on 08Nov2020. The patient was hospitalized for 7 days for COVID-19 from 07Feb2021 or 08Feb2021 when she had "diarrhea coming out both ends", and when she had come home, she had on/off head spinning for 2 weeks and in a month her head stopped spinning. She waited 90 days before getting the vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in a clinical study or a program. Concomitant medications included naproxen (NAPROSYN E) taken as needed for back pain. On 12May2021, the patient experienced injection site pain. On 13May2021, she started experiencing aching all over for about 8 hours and has been hurting all morning from 08:00, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, couldn't hardly walk legs were hurting started today worse, headache, muscle pain, really bad joint pain, chills, feeling really unwell, really weak, heart started beating a little bit fast and shortness of breath. she has no swollen lymph nodes. She stated her back wasn't hurting yesterday and now today (13May2021) she has back pain so much so that she can't hardly get out of bed. She also stated throat hurting. She reported that the persistent/significant aching all over for about 8 hours & "her arm hurt very bad where she got shot, right arm" were serious due to disability/incapacity. If it keeps up like this, she doesn't know if she will take the second one. She is scheduled for her second one on 02Jun2021. Later, she stated, "I was aching about 8 hours. After that I think I had took a Tylenol" but she can't be sure. The clinical outcome of the event "aching all over" was resolved after 8 hours on 13May2021 around 16:00. The clinical outcomes of the events chills and heart started beating a little bit fast were resolving, the events injection site pain, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, headache, muscle pain, joint pain really bad, really weak, throat hurting were not resolved, while the events feeling really unwell, shortness of breath and back pain were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Outbreak of psoriasis with rash and severe itch - I don't think the vaccine caused the psoriasis but it may have made it spread more or quicker. If this has happen to others with psoriasis, than maybe a warning should be given, so an informed decision can be made for future doses.

Two days following the first dose of the Pfizer vaccine, the patient developed redness around the injection site that was hot to the touch. The redness/inflammation did grow to a larger area than just the injection site. I counseled on icing and treating with tylenol, ibuprofen, or benadryl and reporting back if the inflamed area continued to expand to a larger portion of her arm.

Watery itchy eyes; Watery itchy eyes; Itchy nose; itchy nose and throat; itchy head, neck, and body; headache; Tiredness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received first single dose of BNT162B2 (lot Number: PFIZER BION TECH MANUFACTURING) via an unspecified route of administration into left arm on 13Mar2021 at 09.30 AM for COVID-19 Immunisation. Medical history included allergy to salmon, carbamazepine (TEGRETOL), ketorolac tromethamine (TORADOL), lithium, morphine (MORFINE), nova cane, ciprofloxacin (CIPRO), Sulfa, hyoscyamine sulfate methenamine methylthioninium chloride phenyl salicylate phosphoric acid sodium (URELLE), and contrast media allergy. Prior to vaccination patient was not diagnosed with covid-19, and since the vaccination the patient had not been tested positive for COVID-19. Concomitant medications were not reported. The patient experienced watery itchy eyes, itchy nose and throat, itchy head, neck, and body, headache and tiredness on 13Mar2021 at 09.45 am. The adverse events resulted in doctor or other healthcare professional office/clinic visit]. The patient was administered with 2 diphenhydramine hydrochloride (BENADRYL) as a therapeutic measure on an unspecified date. The patient was recovering from all the adverse events at the time of reporting. No follow-up attempts are needed. No further information is expected.

Within 10 days of dose one, severe outbreak rosacea or rash-like effect on face: hot, red and bumpy. Had to see MD for treatment. Also after #2 dose, lot EW0161 given 05/24/2021, same symptoms developed after 7 days from shot date. Again saw doctor this time for treatment.

The first day when I woke up I had really bad back pain and I was really sleepy. towards the afternoon I became very itchy. The itching and hives would become increasingly worse. I didn't take it for anything. On Saturday I went to work still itching I called the nurse at work on the hotline and explained what was happening. I was told to take Benadryl but could not because it would make me drowsy. I finished work and took the Benadryl after. I also started to break out into hives, the itching was turning into hives. On Sunday I got up for work and the hives were large and like welts. This was all over my body. The itching was still present as well. I was advised to go to an urgent care or a doctor. On Monday morning I woke up and everything was swollen: my face, my lips. I went to the Dr's office where they gave me steroids and an epi pen as well as oral steroids. After the steroids, the swelling went down after a few days. The itching had also ceased. The itching lasted from Friday up until Monday when I got the steroid shot on Thursday.

Chills and fever; Chills and Fever/Fever has gotten better went from 103to99; Broke out in rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration, administered in right arm on 18May2021 at 08:30 as single dose for covid-19 immunization. Medical history included breast cancer from 19Jun2019. She had surgery in Jul2019, a lumpectomy and they did radiation on her left breast in Sep2019 and Oct2019 then she went into remission. The patient's concomitant medications were not reported. No prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: unknown) in right arm on 27Apr2021 at 08:30 (at the of 60-year-old) as single dose for covid-19 immunization. She got the shot on Tuesday. When she got her shot she did not start having a reaction until Thursday night. Then Thursday 20May2021 until 22May2021 not having chills anymore, running low grade fever. She had chills and fever on 20May2021 around 5:00 to 6 in the evening. She clarified that it has not went away she is still having a reaction. Her fever has gotten better went from 103 to 99. She took Tylenol and packed herself in ice. Around midnight she broke out in rash on left breast, abdomen and side. It started Thursday (20May2021). It has continued and is persisting. She has taken Benadryl every six hours and ice packs. She is a breast cancer survivor. She is going try to go to the doctor today because her rash is not going away. A visit to emergency room or physician office was not required. The outcome of the events chills was recovered on 20May2021, fever was recovering; rash was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

First covid vaccine 21Dec2020 Had second shot 08Jan2021; Rash in groin / lower abdomen; This is a spontaneous report from a contactable physician. This Physician reported for a 60-year-old female patient in response to HCP letter sent in cross reference case. A 60 year old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EH0899, Exp. Date: 31Mar2021, NDC: 59267-1000-01), via intramuscular in left arm on 08Jan2021 at 10:29 at a dose of 0.3 ml as a single dose for COVID-19 immunization. The patient had no history of allergies to vaccines or injectables. The patient did not receive any recent vaccines for any other conditions prior to the event. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine. The patient's BMI was 26 to 99. The patient had no AE's prior vaccination. The patient's medical history and concomitant medication refer the case 2020512502. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284, Exp. Date: 30Apr2021, NDC: 59267-1000-01), via intramuscular in left arm on 21Dec2020 at 12:52 at a dose of 0.3 ml as a single dose for COVID-19 immunization. After the second dose of vaccination in less than six hours, the patient had no new areas of rash irruption but had new rash at groin, went to her R sternal border and under her breasts, worked its way up to lower abdomen over a few days. A week later occurred on a couple of places on my right chest, sacral area, and nape of neck. The rash was extremely pruritic, red, raised and took another shot prednisone taper and took Benadryl. The patient did not undergo laboratory test. No other symptoms were present. The patient was letting know this in case anyone else has had this issue, that the vaccine can cause a rash. The patient was not sure if this was a side effect or an allergy but if a yearly vaccine was needed, the patient did not think the patient should get the Pfizer vaccine. The patient did not hospitalized and admitted to an intensive care unit (ICU). The patient felt well and declined exam or further medication. No further action was required, and patient was explained that it was difficult to say what the rash was due to but this was not a contraindication to further COVID vaccines and rash may not be vaccine related. The predisposing factors were cestice history and multiple medications. Culture was not performed. The patient did not use any antipyretic. The patient had not experienced any anaphylactic reaction and just a rash 24hrs after both COVID vaccine doses. The patient had no multiorgan involvement, dermatological/mucosal, generalized urticaria (hives), generalized erythema, angioedema (not hereditary), generalized pruritus without skin rash, generalized prickle sensation, localized injection site urticaria, red and itchy eyes, gastrointestinal. Outcome of the event rash in groin / lower abdomen was recovered and other event was unknown. Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.

shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected

pt received pfizer at outside location. Reports day after receiving vaccine had rash for 5 days. Rash: bright red indurated splotches. Located on buttocks, truck thighs, arm. Pruritic and tender. Resolved 5 days later, except for erythematous patch on left medial thigh.

painful swelling of one or more lymph nodes; tennis ball sized knot in the arm; achy; pain and slight swelling at the injection site; pain and slight swelling at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot Number: EN6203 and Expiry date: Unknown), dose 2 via an unspecified route of administration, on 05Mar2021 at 10:45 as 2ND DOSE, SINGLE for covid-19 administered in Arm Left immunization. Medical history included osteoarthritis, fibromyalgia, asthma and allergy to several foods. The patient did not receive any other vaccine in 4 weeks. Patient was not covid positive prior vaccination. The patient previously took celebrex and experienced Celebrex. Historical vaccination included the patient received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry date: Unknown), on 06Feb2021 at 10:45 am for COVID-19 immunization . On 05Mar2021 at 18:00, the patient experienced pain and slight swelling at the injection site, tennis ball sized knot in the arm and achy on 06Mar2021 and painful swelling of one or more lymph nodes on 07Mar2021. It was reported that on evening of injection (Friday) the patient had pain and slight swelling at the injection site. The next day (Saturday), she had a tennis ball sized knot in the arm which was slightly achy but not really painful. When she woke up on the second after the vaccine (Sunday) she noticed a somewhat painful swelling of one or more lymph nodes under her left arm extending slightly into her left breast. A hot shower has alleviated some of the swelling and pain so far. she expected this would ease up in the next few days. If it does not, she would seek medical advice. No treatment was given for the events. Patient was not tested for covid post vaccination. Outcome of the events were resolving. No follow-up attempts are possible. No further information is expected

Headache; pain; site pain; Dry cough; Sneezing; This is a spontaneous report (letter response) received from a contactable consumer. This 60-years-old female consumer reported. A 60-years-old female patient received second dose of BNT162B2 (BNT162B2, Pfizer-BioNTech COVID-19 Vaccine, Solution of injection, Lot Number: EN6208), via intramuscular, administered in left arm on 31Mar2021 at 11:30 (at the age of 60-year-old) as 2nddose, single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot number: EN9899) on 23Dec2020 at 10:00 via intramuscular, administered in arm left for COVID-19 immunisation and tested positive for Covid (drug ineffective), symptoms similar to flu, Loss of taste, Loss of smell, Body ache, On 28Dec2020 she went to hospital to get neurocloral infusion. Medical history included, seasonal allergy and concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); metoprolol (METOPROLOL); atorvastatin (ATORVASTATIN). On an unspecified date, the patient experienced headache, pain, site pain, dry cough, sneezing. The patient still had dry cough. The patient did not require medical intervention. The patient was visited the emergency department. The patient was not hospitalized. The patient was not admitted to an Intensive Care. There is no information about organ involvement. On 27Dec2020, the patient underwent lab tests and procedures which included covid-19: positive. Patient was treated with Advil also took Vit D, Vit C, Zinc Nuletomy for sneezing and dry cough. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The outcome of the event dry cough was not resolved and other events was unknown. No follow-up attempts are needed. No further information is expected.

needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotated out everywhere after 30 minutes; burn a little regarding; incapacitated; injection site swelled and turned red; injection site swelled and turned red; non-anaphylactic reaction; nightmare; Bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Feb2021 (lot number: EN6198; expiration date: 30Jun2021) as 1st dose, single, dose 2 via an unspecified route of administration on 15Mar2021 (lot number: EN6204; expiration date: 30Jun2021) as 2nd dose, single for COVID-19 immunisation and varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration, administered in left deltoid on 01May2021 (lot number was 9NH54 and expiration date was 14Oct2022), at an unknown, single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient family history included shingles (caller mother had shingles). On an unspecified date, the patient experienced needle was put in and burned like hell and her head kind of exploded, arm was throbbing, pain rotated out everywhere after 30 minutes, burn a little regarding, incapacitated, injection site swelled and turned red and non-anaphylactic reaction. The clinical course of the event was reported as: caller stated that her pharmacist told her to report because she had Shingrix vaccine injection on 01May2021 and had a non-anaphylactic reaction but her reaction was epic and her pharmacist said that the company would want to know this information for the numbers related to the product. It was reported that her weight was when she was fully dressed. The caller stated for Shingrix vaccine, the needle was put in and burned like hell and her head kind of exploded and that was epic. The nurse said it did burn a little regarding the patient stating Shingrix vaccine burned upon administration; stated the nurse let her go but she wanted to stay in the store for a few minutes and it felt really awkward; her head settled down and her arm was throbbing and started screaming; stated the pain began in her lower back and her arm, head and right side of her hip and moved throughout her body and the pain rotated out everywhere after 30 minutes the pain settled down and she just had the pain in her arm. She stated the area where Shingrix was injected was almost like a baseball sized circle and was read and she had to drive to care for her parents and that made this a nightmare. She removed the band aid from the injection site because the band aid caused a bruise and the injection site swelled and she remembers taking the band aid off and not being able to put ice on it and could not bear the pain. She could not put ice or clothes on top of the injection site and could not take it. She reported her head was just killing her and it was ridiculous to had to use that arm and to lift it like a disabled arm, she would say she was incapacitated and only if forced could she do something under those conditions. She stated the injection site swelled and turned red and just continued to swell, turn red and was burning and hurting and did not go farther and was the size of a baseball. She reported that the other symptom was she had her head back down and no pain in her back anymore, no pain in her chest anymore, and no pain in her legs anymore. She stated the pain after Shingrix vaccine was localized but gave her a headache; states using that arm was insane and if she was not forced to use the arm she could not use it effectively and this was not an anaphylactic reaction and the reaction was not moving anywhere else; stated the area of the injection site is now black all around it like the nurse gave a bad vaccine but she did not do a bad job; stated she could see the dot where the Shingrix vaccine went in. Stated the indication for which she had Shingrix vaccine was that her mother had shown up with shingles and they took her to the emergency room on Sunday (as reported) with a rash that began to bubble so the caller called for her mother; stated her mother was transported to the hospital and the caller had been wearing gloves and thought it was contagious and it was shingles; states the six doctors for her mother in the ER pressed the caller to get Shingrix vaccine. Caller stated the reported reaction for Shingrix vaccine lasted 11 days and sort of calmed down and all she could see now was the red dot where the vaccine was administered; stated she was sure she would have to do Shingrix again due to her reaction and did not have an anaphylactic reaction but wanted to report this as she was told. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest were all very red and flushed; Her face, neck and chest were all very red and flushed; This is a spontaneous report from a contactable consumer (patiemt). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 04Mar2021 13:00 (at the age of 60-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included shellfish allergy from 2011 and ongoing (patient had an Epi-pen prescription on her patient portal information but she has never filled or used that prescription), pneumonia in 2017 and 2018 (occurred 2 years in a row, probably around 2017 and 2018), bronchitis from 2016 (one year bronchitis without Pneumonia, may have been 2016), prediabetic (Onset date: Probably 2015), obesity (Onset Date: Probably 2000), compromised immune status, blood pressure and thyroid. Concomitant medications included lisinopril taken for blood pressure from 2016 and ongoing; atenolol taken for blood pressure from an unspecified start date and ongoing; amlodipine taken for blood pressure from an unspecified start date and ongoing; hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; levothyroxine taken for thyroid from 2016 and ongoing. On 04Mar2021 about at 13:50 the patient experienced odd sensation in her mouth, difficulty swallowing, mouth full of saliva, and her face, neck and chest were all very red and flushed. The patient stated that it was a slight reaction. The patient reported that she received her first dose of Pfizer COVID-19 Vaccine on 04Mar2021. She waited the 30 minutes and then left. As she was driving home felt she felt an odd sensation in her mouth, had difficulty swallowing and her mouth filled with saliva; so she pulled over and she looked in the mirror she was all red, her face, neck and chest were very flushed. She just did some breathing and tried to relax. She called her doctor and waited to hear back from her but didn't yesterday. She tried to drink water and just relax; she did not feel like she had to go to the emergency room. Her doctor got back to her today and had a teleconference. The patient did not have other vaccinations within four weeks prior to the first administration. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Bright red rash starting to turn purple; raised, angry rash raised, angry rash all overback, chest, abdomen, neck and face.; raised, angry rash all over back, chest, abdomen, neck and face; Swollen right side face including cheek, eye and ear; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old adult non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 10:45 AM (at the age 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Lyme disease, PCOS, asthma, rosacea, Hashimotos thyroiditis, diverticulosis, celiac and IBS. Multiple food and drug allergies reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17Mar2021 at 05:00 AM, patient experienced raised, angry rash all over back, chest, abdomen, neck and face. Rash was bilateral and worse on right side. Patient also experienced Swollen right side face including cheek, eye and ear and bright red rash started to turn purple as the day passed. The patient did not receive any treatment for the events. The clinical outcome of rash all over back, chest, abdomen, neck and face, swollen face and red rash was recovering. Information about lot/batch number cannot be obtained. No further information is expected

I was unresponsive, he could not wake me up; Had pain in my neck on the same site of the shot; Had pain in my neck on the same site of the shot.; Nerve pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration, administered in left deltoid (left arm) on 17May2021 (at the age of 60-year-old, Batch/Lot Number: EW0177) as a single dose for Covid-19 immunization. Medical history included the patient had a child arrhythmia; she believed it was from 1996 but it pretty much controlled and prior to vaccine. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This report was not related to a study or programme. The patient stated that she had a concern because she took the first COVID vaccine on the 17May2021 and she was due to get the second one on the 07Jun2021 however she had some concern today. The patient stated that she had some changed episode of reactions on 17May2021, she started having pain, after she took the first one, on the same day, she had pain in her neck on the same site of the shot and had some effect of pain, a nerve pain and it had devastated to the back of her neck where she had her thick neck and she had to use warm pack on the back of my neck. It would be about 4'O clock in the morning which would be on the 18May2021 her husband was observing her because he is a nurse and he could not wake her up, he tried everything possible to wake her up and he attempted to perform cardiopulmonary resuscitation (CPR) on her, so she was concerned about putting herself again such an event taken place. The patient went to the emergency room. They took her to the emergency room however she got her name administered in 'first a clinic' and he was able to stabilize her. The patient went to the emergency room and when she got there it was like a concerning so when she got there, she was not seen by the doctor because she was feeling little better but the context person, and they did concern that some of the episode she had, she saw the effect after COVID vaccine, she was concerned because she was due for the second vaccine and this was the first episode which she had, and she was concerned whether not should, she take the second shot, she went on her and she reported. The patient could not get this anyone, all she got was the worst. They took her to late but whatever she never got a chance to speak with anyone in her life, you know she do consult with her doctor has followed her so she was concerned now that she would have a second shot, she did not know if she could really take it. When concern confirmed the patient stated that she did have adverse reactions to the Covid-19 shot. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

severe chills; severe soreness in shot area; lethargic; This is a spontaneous report from a contactable other HCP. A 60-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered in Left Arm on 10Feb2021 as single dose for (at the age of 60-year-old) covid-19 immunization. Medical history included arrhythmia neonatal, thyroid disorder, gout and umbilical hernia. Other medical history reported as tachy-Brady syndrome, thyroid, gout, umbilical hernis. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had tested with covid 19. No known allergies reported for the patient. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); allopurinol (ALLOPURINOL); and digoxin (DIGITEK). These Other medications are administered in two weeks. On an unspecified date the patient experienced severe chills, severe soreness in shot area and lethargic. No treatment received for the event. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

2nd dose: Stinging a few minutes after shot, I felt really woozy, and then started shaking all over having a hard time processing and talking. Went home the next day (Wed) fever, chills, headache, 24 hours better, returned to work on Thursday, day (2). Day (3), Friday, I noticed a red rash at the site of the injection earlier in the day, but no symptoms, just a little tender. Friday evening I noticed a little SOB, a little burning sensation under my skin on both forearms, and a couple times felt a little dizzy, but I didn't think much about it. Day (4) Saturday morning, I went to spin class, I felt a little off, halfway through spin class I noticed I was struggling with some breathing, thought it was because I was wearing mask, but pushed through. Ran a couple of errands afterwards and then noticed the SOB was continuing, my skin started burning again under forearms and now my legs with tingling into my feet. At this point I decided I probably needed to go home. On my way home my chest started to hurt in the very center of my chest, and slowly felt like some pressure, with squeezing sensation. Then starting at the center of my chest I could almost feel what felt like a numbness creepy from my chest to my throat. I went to the ER. My legs felt really wobbly and had a difficult time walking, and was feeling dizzy. They ran a variety of blood work and tests. They noted my D-dimers were elevated and (4) lymph nodes enlarged. They ran an additional series of test and released me at 10pm with follow-up to cardiologist. I am still experiencing SOB, not as bad, and the burning sensations under my skin.

Shingles outbreak on same side as vaccine administration. The last outbreak of shingles I had was approximately 5 years ago.

Hypersensitivity; I feel like I have a arthritis like rheumatoid arthritis in my hands; little tender on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm/ feet are swollen; mild chills; body aches; weird muscle; fatigue; Diarrhea; had marking on my legs actually in elbow area; had like ulcers in my mouth; I lost in the meantime, currently now I am 108 pounds; Bone Ache; blistering in the mouth; blisters; sandpaper like rash on the hands and the feet's; mild rash and itchiness on the arm; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 17Feb2021 Arm Left at the age of 60-year-old as 2nd dose, single (Lot # EN6201) for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Anatomical location: Left Arm for covid-19 immunisation. The patient had it, 2nd one was then on 17Feb2021, 10 days later had a guess what you call hypersensitivity because that is the thing can relate to and the they had at the urgent care (emergency room visit) and then the hospital (further not clarified) because had therapy in multiforme. Symptoms on 27Feb2021 and then had gone through an urgent care that following Tuesday and Thursday went back. So, thought it was from that. She had the initial little tender on the arm and it is swollen and little itchy and then had mild chills and body aches initially and did not take, that is better than other people are having with headaches and everything else but it was 10 days later that had this multiforme beginning of this blisters (27Feb2021), sandpaper like rash on the hands and the feet's (27Feb2021), blistering in the mouth (27Feb2021) and had that everything multiforme all over body it is in neck and head. After the 2nd shot on 17Feb2021. She have been mild rash and itchiness on the arm and then little bit of mild chills and mild body ache, it was nothing serious or anything took a steroid and then 10 days later have little bit of sensitivity on index finger and middle finger and then from the next day had marking on legs actually in elbow area, thought it was mosquito bit because of the experienced of itchiness and then it progressed and migrated upward had sandpaper and blisters on face, hands and feet. The rash was on under, it progressed from the ankle and up through the shoulder and had the blister and sandpaper, rash feeling on hands and on feet and then had like ulcers in her mouth. She also had weird muscle and bone aches, body aches and fatigue and diarrhea and everything but she still had she felt like she had a arthritis like rheumatoid arthritis in hands and feet are swollen. She lost in the meantime, currently now was pounds. Treatments included a corticosteroid shot (Further not clarified) and took steroid for the 5 days at the hospital (further clarification unknown) they give her the shot, corticosteroid shot and then took the pills for the 5 days. Outcome of the events was unknown.

I had a headache, chills, and a fever. Then I had tingling in my head. I started breaking out in a rash all over my face, especially on the right side and near my eye. My face swelled up completely. I went to the ER. I was diagnosed with Shingles. I was given nerve pain medication. Later I saw another ER doctor and I was given an antiviral & steroid medication, but I was nervous to take it. I then visited my PCP, where they checked my eye.

developed a "severe reaction"; body aches; constant rash; burning sensation on the back; fever; she feels uncomfortable; has stomach issues; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number was not reported expiry date was not reported) dose 1 via an unspecified route of administration on 04Mar2021, as FIRST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient developed a severe reaction, with body aches, constant rash, burning sensation on the back, fever, she feels uncomfortable, tired, and has stomach issues. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

severe headache; major rash with prickle feeling on face, chest, both arms; major rash with prickle feeling on face, chest, both arms; lethargic; This is a spontaneous report from a contactable other-healthcare professional (patient) reported for herself. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6202, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 03Mar2021 11:45 AM (at the age of 60-year-old) as 2 ND DOSE, SINGLE for COVID-19 immunisation at public health clinic. The patient medical history included tachy-Brady syndrome, thyroid, gout and umbilical hernis. The patient had no known allergies. The patient previously received her first shot of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN9810, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 10Feb2021 (at the age of 60-year-old) as 1 ST DOSE, SINGLE for COVID-19 immunisation and had severe chills, severe soreness in shot area, lethargic. The patient received the medication within 2 weeks included Synthroid, Allupurinol and Digitex. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 03Mar2021 at around 15:00, the patient had experienced severe headache, major rash with prickle feeling on face, chest, both arms and lethargic. The patient did not received treatment for adverse events. The outcome of all events was resolving. No follow-up attempts are possible. No further information is expected.

Approximately 5 days after the patient received her first dose of the Pfizer COVID vaccine, she developed shingles. She was properly treated and received her 2nd dose on 5/5/21

Major case of shingles; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EP6955, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration, administered in Left arm on 25Mar2021 at 07:30 (at the age of 60-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included covid-19, a year ago in March. The patient had no allergies to medications, food, or other products. Other conditions and Investigations were not provided. Concomitant medications included losartan (LOSARTAN) taken for an unspecified indication, levothyroxine sodium (SYNTHROID) taken for an unspecified indication on an unspecified date received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination in march a year ago. The patient has not been tested for COVID-19 since the vaccination. It was reported other vaccine same date details: 25Mar2021. It was reported that, the patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0167), via an unspecified route of administration, administered in Left arm on 13May2021 at 11:00 for covid-19 immunisation. On 10Apr2021 at 13:00, the patient had Major case of shingles/shingles two weeks after her first dose of the shot, which she reported to Pfizer already. Adverse event resulted in Emergency room/department or urgent care. Treatment for adverse event included Valtrex. The patient received 14 days of antiviral therapy after the first dose for shingles. She wanted to know if she can take the antiviral again prophylactically, so she does not have shingles again after her second dose yesterday (received after 50 days from the first dose). Caller stated that others have developed shingles after the vaccine so it would be a side effect. She said she has two doctors that said for her to wait to have her second shot, until her shingles symptoms cleared up, so she had her second shot yesterday. She said she had her second COVID shot at about 50 days out from her first dose. She said her question was that she was wondering because she was not sure if she might get another case of shingles from the second shot, if she should start an antiviral medication to prevent that, but she doesn't want to jeopardize the Pfizer COVID-19 vaccine. She says she has seen where a lot of different people, including four of her neighbors, got shingles after getting the Moderna or Pfizer COVID-19 shot. The reporter wanted to know if she can start an antiviral medication to prevent getting shingles again from the Pfizer COVID-19 vaccine and if antiviral would affect the efficacy of the Pfizer covid vaccine and interfere with the vaccine? She said her first dose LOT: EP6955. She said this dose was injected in her left arm. The reporter declines to complete reports on her neighbours who had shingles after their first doses and said she doesn't have their information to provide. She said she told them they should report it, she said she doesn't know their information, but her colleague also has two friends that got shingles as well. No further details reported, captured, or documented about her neighbors or her colleague's friends. Caller said that she has no new things to add to her previous report. The reporter assessed event as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused or prolonged hospitalization, Disabling or Incapacitating, Congenital anomaly or birth defect. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021551647 same reporter/drug/event, different patient

I woke up one morning with a rash on my left torso. I called my doctor. The nurse practitioner diagnosed it as Shingles. I was prescribed an antiviral for seven days. I experienced some tiredness and achiness as well. There was itchiness from the rash that occurred but it gradually went away. Though the rash itself took 4 weeks to completely go away.

Slight headache; sore arm where vaccine was administered; This is a spontaneous report from a contactable consumer (patient herself) reported that a 60-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 10Mar2021 at 10:00 AM as a single dose for COVID-19 immunisation. The patients medical history included High blood pressure and has no allergies. Concomitant medications included Rosuvastatin 10mg, and Metoprolol Tartrate 50mg. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021 at 10:00 AM, the patient experienced Slight headache and sore arm where vaccine was administered. No treatment was received for the adverse events. The patient was not diagnosed with Covid-19 prior vaccination and has not been tested for Covid-19 post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

hurt more; rash itching; redness; Developing the short sight like a rash and it's you know kind of puffy and hot; Developing the short sight like a rash and it's you know kind of puffy and hot; at the injection site is itchy, rash and swollen; at the injection site is itchy, rash and swollen; at the injection site is itchy, rash and swollen; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female consumer (patient) reported that: A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0177; Expiration date: Unknown), via unspecified route of administration injected in upper left arm on 27May2021 as single dose for covid-19 immunization. The patient medical history included immediate allergy to penicillin. The patient's historical vaccine included first does of bnt162b2 on 06May2021. Past drugs included penicillin and fexofenadine (ALLEGRA). The patient called to inquire that she had taken fexofenadine (ALLEGRA) in the past and whether she can put diphenhydramine (BENADRYL) on it. She was responded from the attached CONS. The patient stated that she had received the second dose of bnt162b2 on 27May2021. She stated that on an unspecified date in 2021, it hurt more, and she was experiencing rash and itching. She said, the week prior to that little bumps on legs which was last Tuesday and dose was given on Thursday. She was asking if this was a reported adverse event greater than Day One post vaccination. The patient was responded from attached and Full EUA Prescribing Information 6.1 Clinical Trials Experience LAB-1457-9.0 Revised: 19May2021. The patient stated that she had called three times and was given VAERs information. The AE was E-transmitted and she was referred to HCP. The report was not part of study or program. The patient stated that she had developed short sight like a rash and it was kind of puffy and hot on an unspecified date in 2021. The patient did not specify seriousness of the events itchy rash, puffy skin and feeling hot. The patient stated that she got her second shot last Thursday, which was on 27May2021 and she noticed some redness and stuff, but she didn't get sick at all after the next day or anything like that, but today she was developing the short sight like a rash and it was kind of puffy and hot. She did not know if that was normal. She inquired whether most people will get the reaction right away. She confirmed that it was Pfizer COVID-19 vaccine. When informed about the Pfizer medical information department for the concern, the patient stated that they gave her a number and said to press 3 already. She was informed that after dialing the number, she needs to press option 3 to reach the department. The patient stated that that's what she did and then they asked her for another option and then another option. So, she pressed option 3, then option 2 and then option 1. The patient was informed that in order to reach the Pfizer Medical Information Department she needs to press option 3 and if she pressed option 1 then she would reach Department. The patient stated that she did exactly the same and that's how she got connected to the Pfizer Department. She was informed the role of Pfizer drug Safety Department and asked for permission to probe questions, upon which the patient replied that she just wanted to talk to somebody who could tell her whether it was okay. She wanted to check if anybody has had it and said that she was actually at work and was trying to get to the Pfizer drug Safety Department before 8 o' clock. The patient was provided with timings of Pfizer medical information department as 8 AM to 8 PM on Monday to Friday and 9 AM to 3 PM on Saturday and Sunday, EST. The patient was unwilling to complete the report. Hence, limited information was available. The patient called again and stated that she experienced "injection site is itchy, rash and swollen" on an unspecified date in 2021. She was unsure about the lot number whether it was EW "O" 117 or EW "zero" 117. Expiry date of the covid-19 vaccine was unknown. The patient stated that she called because she had the second shot on last Thursday, and she did not know because she did not have any reaction to it, but today (on an unspecified date in 2021) "at the injection site is itchy, rash and swollen". She wanted to know whether it was normal. She confirmed that the shot was of Pfizer Covid 19 vaccine. She confirmed her second shot was on last Thursday, on 27May2021. She stated that the first shot was three weeks apart to that. She did not recall the exact date, but believed it to be Thursday. She stated it was 06May2021, which was 21 days apart. She was unsure of the lot number whether it was EW, zero or O, 177. The outcome of the events were unknown. Further probing was not done hence limited information available over the call.

This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 pm (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP) and oyster allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 11:00 am as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 18Mar2021, patient experienced soreness at injection site, headache and chills. No therapeutic measures were received for any event. The clinical outcome of the events soreness at injection site, headache and chills was resolved on 18Mar2021. No follow-up attempts are needed. No further information is expected.

soreness at site of vaccine when lifting arm and some movements, tender to touch-mild; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration administered in left arm on 13Mar2021 at 13:45 (at 60 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included allergic rhinitis and known allergies: peanuts and penicillin. The patient previously took vancomycin and experienced allergies. Concomitant medications included fluoxetine, fluticasone propionate (FLONASE), calcium, vitamin B complex (B COMPLEX), and colecalciferol (VIT D3); all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced only soreness at site of vaccine when lifting arm and some movements, tender to touch-mild; non-serious on 13Mar2021. No treatment received for the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

12/28 developed shingles for the first time. Started antivirals 12/31when vesicles appeared and I realized it was shingles.

Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.

VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .

development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all over body--temp 96.8 temporal but felt very, very warm took Benadryl rash faded, decreased itchiness

rash/legs are all rash/checked her back and told her there was a rash; itchy in back; This is a spontaneous report from a contactable healthcare professional. A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 22Dec2020 at left arm at single dose for COVID-19 immunisation. Medical history included ongoing diabetes from about 3-4 years before, and an allergic reaction to the dye when testing heart - couldn't remember the dye put in. She was allergic to that and sent to the ER because her throat was starting to close up about 3 years before. Concomitant medications were none. Patient received the Covid vaccine and developed rash on 24Dec2020 that was worsening and she asked if there was any recommendation on whether this was it going to get worse. Patient received the vaccine and was very worried because she was really itchy in back and her legs were all rash and in her back. She was starting to itch really bad. This was after 2 days of the vaccine (on 24Dec2020). She didn't take note until it came to her back and her friend checked her back and told her there was a rash. She asked if this could be related to the vaccine. She asked was this a severe reaction and should she receive the next dose. Her second dose was scheduled for 08Jan2021. She did not know at this time if she would get the second dose as scheduled or not. Onset of rashes started on her legs; she thought it would go away; but the rashes had worsened; they were now on her back and were getting really itchy; she had a friend look at it who told her she had patches of rashes on her back. She reported that she was going to contact her doctor about this information because she was scared about the rashes. Outcome of the events was not resolved. Lot/Batch and Expiration date has been requested.

Developed itching on right side of face between temple and earlobe while driving home. Once home was noted to have 3 dime sized hives in that area which lasted approximately 2 hours and then resolved without intervention or further adverse event.

Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.

Shingles; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number PAA156571) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history included hypercholesterolemia. Concomitant medications were not reported. The patient took unspecified medication for hypercholesterolemia however the patient stopped taking it for a month or two already. The patient got the first Pfizer vaccine shot on work (clinic) on 20Dec2020. On 28Dec2020, the patient developed shingles which is now being treated. The patient does not know if this is because of that or a part of it. The patient never had Shingles before. Outcome of the event was unknown.

Pfizer-BioNTech COVID-19 Vaccine EUA Beginning one week after receiving the injection, the site has a red spot about the size of a quarter and feels slightly irritated. It has been this way for approximately 24 hours.

Ee stated upon observation entrance, that she would be observed until 10:15am r/t "anaphylaxis" to Morphine. Informed us that she became "itchy" for "3" days prior to the 1st dose on 12-16-20. Ee c/o "itching" to this nurse @ 1005. Benadryl 25mg given @ 1005. Remains to c/o "itching" @ 1015. Ice pack applied to chest to relive itching @ 1015. Around 1025 Ee stated she felt "relief of itching". This nurse also gave Ee (1) Benadryl 25mg to take w. Her. Ee stated she was feeling better @ 1034. Left observation @ 1035.

pain in arm at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, expiry date not given), intramuscular on 29Dec2020 18:00 at a single dose in the left arm as Covid Vaccine. Medical history included hypothyroid, low adrenal cortex and allergies to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Concomitant medication included fluoxetine. The patient had no vaccine in four weeks. The patient previously took amoxycillin and experienced allergies. On 29Dec2020 (reported as at 5:30 AM and 5:00 AM; pending clarification), the patient experienced pain in arm at injection site. Since the vaccination, the patient has not been tested for COVID-19. The event reported was not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the event pain in arm at injection site was recovering.

couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.

Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine. Pt stated that her throat is dry and feels a sensation to cough. Pt stated that started feeling swelling of the tongue 30 minutes after administration of the vaccine. Pt was given water and says that it helped relieve itching. Pt was given benadryl 25mg IM and is being monitored. Charge nurse is taking over monitoring and care of patient.

2 days after receiving 1st vaccine, began with hives and itching to arms face and torso. Also after 24 of receiving 2nd dose began with hives and itching to face hands and arms.

Mild- moderate tenderness in left deltoid; This is a spontaneous report from a contactable physician. A 61-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=EK 9231, via an unspecified route of administration, in left arm, on 30Dec2020 at 13:45 (at the age of 61 years-old for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included allergic rhinitis, a distant history of thyroid cancer and an allergy to iodine. Concomitant medication included biotin (BIOTIN), cetirizine (CETIRIZINE), fish oil (FISH OIL), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levothyroxine sodium (SYNTHROID). . The patient has not had any vaccinations in 4 weeks. The patient has taken other medications (concomitant medications) within 2 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Dec2020 at 0700 the patient experienced mild- moderate tenderness in left deltoid. The patient was not hospitalized for the event nor received any treatment. The clinical outcome of the mild- moderate tenderness in left deltoid was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.

1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM

Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; temperature 102; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer-BioNTech ;lot number: EK9231) intramuscularly at right arm on 02Jan2021 at 07:45 A.M. at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 on 07Dec2020. No known allergies (no allergies to medications, food, or other products) and no other medical history. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination were none. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included chills, temperature 102, general aches, fatigue, pain at injection site, dry cough, general malaise, no appetite. Temperature elevated till 03Jan2021, 6pm. Symptoms similar to what she experienced when diagnosed with covid-19 on 07Dec2020. All events with start date on 02Jan2021 at 06:00 P.M. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Since the vaccination, the patient had not been tested for COVID-19.

muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast

About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.

Extreme skin sensitivity to torso (chest & back) on left side parallel to the injection site, shingles type sensitivity without a rash or redness

Raised red itchy rash on left palm of hand, evaluated by pharmacy, diagnosed as Shingles onset same day as Covid-19 vaccine obtained.

24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair

Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after receiving dose

injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol

Received her 2nd dose of the covid vaccine on 1/8/2021. No side effects all weekend. Woke up on 1/11/2021with systemic hives, rashes that itch. Denies prior reaction to previous variance dose #1 on 12/18/2020. Denied any difficulty breathing or SOB. Took 25 mg of Benadryl this am and then called PCP who is a OB who said to take 50 mg of Bendery and if symptoms do not improve go to Urgent Care. Follow-up call made by provider 1816: Employee reported going to Urgent Care where she recieved Soulmedrol IM and an AB test. Hives covering entire body and scalp.

Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.

Patient reported rash on left wrist approximately 10 minutes after receiving vaccine. Also reported pruritus at site of redness. Patient was monitored by provider and throughout duration of monitoring developed rash on wrist, neck, and left forearm with pruritus at all sites. Patient given 50mg of Benadryl PO approximately 25 mins after reaction. Within 30 mins of administering medication redness and pruritus had resolved and patient left clinic in stable condition.

notice a rash on her left hand; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via unspecified route of administration on left arm on 05Jan2021 at single dose for Covid. The relevant medical history and concomitant medications were reported as none. The patient stated that she just got the first shot of COVID vaccine and noticed a rash on her left hand. She stated that it was the same arm that she got the shot. She wanted to know if there was anything that she needed to do. She stated that she got it through the state as a healthcare worker. She stated that she noticed the rash 20 minutes prior to the report. The patient had no treatment for the event. The patient was tested for COVID the week prior the report in Dec2020 and it was negative. She was going in at the time of the report to get another COVID test. The outcome of the event was not recovered.

rash started 15 mins post administration on left arm, and spread to chest, and other arm treated with Benadryl

fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.

Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (Patient) reported for a 61-year-old female patient received the first dose of BNT162b2 (lot: EK92331), intramuscular at left arm on 04Jan2021 (approximately between 18:15-18:30) at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications included supplements. The patient experienced soreness and swelling at injection site, malaise and feels tired on 05Jan2021 08:00. She was scheduled for second dose a day later for COVID vaccine so after the 21 days to get her second dose. Patient is a Dental Hygienist. She received the first dose on 04Jan2021 and is scheduled to receive second dose on 26Jan2021. She should have it scheduled for 25Jan2021. There is no prescriber. She received it at a local hospital through her employer. They did not offer her the 25Jan2020, and said next day is 26 days. They told her there would not be any problem being a day late. She called back with a concern and had evening appointment with the intention of being 3 weeks later. She did it while she had 2 days off work in case she had a reaction. She was told it was not a big deal to get it 1 days later. She asked if she could go to a different location and they told her no, it had to come from the same batch and lot to receive second dose. She is just concerned about doing it a day before she has to go back to work because there are worse side effects with second dose. There is a 4 day grace period from what she read of of 17-21 days and not over 21 days. She is not sure if that is true though. The outcome of the events was not recovered.

Itching at site. Removed bandaid. Reddened area in triangular pattern along bandaid and below bandaid approx 3 inches. Site not hot, site firm. By 10:00 pm itching and redness resolved. Site remains slightly firm.

Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days

chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable consumer (patient herself) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Patient had a history of COVID in Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID) (for twenty some years), bupropion hydrochloride (WELLBUTRIN) (for about a year), naltrexone (for about a year), all from an unspecified date and ongoing. The patient got the vaccine yesterday (06Jan2021). Patient experienced chills, body aches, cold, fever, and pain at the injection site started at 10 am on 07Jan2021. The fever has went up a little since this morning, but everything else has stayed the same. Her fever was 100.6 degrees Fahrenheit now. Earlier this morning it was 99.3 degrees Fahrenheit. Outcome of events were not recovered.

As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. I fell forward and sustained bruising to my right cheek and temple. I will be reporting another report regarding the second dose with adverse reaction that is the same but required EMS and Emergency Room visit. Approximately 3 hours after injection I was getting ready for bed (as I work nights). I was talking with my daughter and I stood up and remember waking up on the floor. Bruising to the right cheek and temple. I did not seek medical attention and went to bed. I had no further episode but remained dizzy for several days.

Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.

Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site.; This is a spontaneous report from a contactable pharmacist (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included diabetes and hypertension (HTN). It was also reported that the patient had allergies with quinolones. Concomitant medications included metformin (METFORMIN), cetirizine hydrochloride (ZYRTEC), semaglutide (OZEMPIC), simvastatin (ZOCOR), levothyroxine sodium (SYNTHROID) and "elav". On 01Jan2021 19:00, the patient had extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site. The patient also had shingles type reaction without a rash or redness. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the events were not recovered.

Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.

trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; bad neck and shoulder pain; sore right arm similar to after a tetanus shot; This is a spontaneous report from a non-contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL1284, intramuscular on right arm from 05Jan2021 09:45 to 05Jan2021 09:45 as single dose (first dose) for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 05Jan2021 at 03:00pm, the patient experienced sore right arm similar to after a tetanus shot. On 06Jan2021, the pain in upper arm gone but by afternoon but the patient got bad neck and shoulder pain on right side that she treated with heat and Advil. On 07Jan201, neck pain still present and by late afternoon, the patient got a lot of pain in right elbow. On 08Jan2021, the patient still have the neck to shoulder pain in addition to the right elbow pain. It feels like she sprained her elbow and was having trouble lifting things like my tea kettle. The outcome of the event sore right arm/pain in upper arm was recovered on 06Jan2021; having trouble lifting things like my tea kettle was unknown; while the other events were not recovered. Treatment has been given for the event bad neck and shoulder pain. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.

minor itchy spots torso and neck. started 24 hours after shot. first 7 days just 2 to 3 spots daily. days 9 thru 11 spots increased to about 8 to 10 daily. These spots only lasted about a day. They did not break open, merely disappeared with no lasting marks. There has been no new spots after day 14. No medications was take, it was mild and I wanted to watch what would happen without treatment.

Total body rash with severe ankle and feet swelling and peeling that continues even after getting vaccine more than 3 weeks ago

"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.

i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever. 1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil.. 1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.

Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.

Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later. I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.

Redness, sore, large bump and itching - no change since original symptoms. 3 days later still have a large bump under site given, itching and soreness.

she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.

itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.

Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.

I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.

adverse affect was on 1/12 and was diagnosed by her PCP with Shingles. Today, 1/20, remains with Shingles, with rash, itchy and pain.

Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.

I developed mild itching of my right forearm and abdomen at 2100 but about 2300 I awoke with severe itching from my head to my hips--no rash. 1 Benadryl did not help, so about another 1.5 hrs later I took another Benadryl and that made the itching tolerable. Having taken 50mg Benadryl I was not able to work at 0430 the next morning as scheduled. The itching continued even with Benadryl every 8 hrs until mid-morning of 12/30. I got the 2nd dose 1/20 & --per the advise of my GP premedicated with 50mg Benadryl, 20mg Pepcid, and 1000mg Tylenol 45 min before the 2nd dose; then I repeated 25 mg Benadryl at bedtime. I developed itching again about 8 hrs later but it resolved by the next morning and was not as intense as with the first dose.

Patient was vaccinated at work on 1/16/21 and developed rash the morning of 1/18/21. It started on the neck / chest and gradually spread to abdomen, back, and extremities. She took Benadryl on 1/20/21 with mild improvement. Rash is described as pruritic. Patient reported to clinic on 1/21/21. At that time rash was present on the neck, back, chest, and lower extremities. Appearance was pink, 1 cm discrete wheals with areas of coalescence especially on neck where it was more excoriated. Patient was treated with prednisone, topical steroid cream, and hydroxyzine. Treatment response is unknown at this time.

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs.

Extremely lethargic Swelling in vaccinated arm Pain in vaccinated arm Body aches Headache Congestion

Extreme soreness at injection site. Impacts ROM. Painful to lift left arm above head. Pain starts below the left AC and extends up to the acromion process. Intermittent relief when taking OTC pain medications.

AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CHILLS 1/26/21 PM ALSO

felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.

My eye is swollen, I have knots on my forehead over my right eye. I thought it was a spider bite but now I am not sure

day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around the shot area.

in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt warm. extreme tinnitus. took Benadryl and slept. after 5 hours, symptoms came back. feels like lower jaw is pulling to right. took more benadryl.

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

Began with pain to injection the same evening of injection on Sat 1/23/21, then 2 days later on Mon 1/25/21 with some redness around injection, no drainage or fevers.

(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.

exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 10Jan2021 at 15:30 on her left arm at a single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing and known penicillin (PCN) allergy. There were no concomitant medications. The patient previously took erythromycin and clindamycin and experienced allergies. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm on 20Dec2020 at 03:30 PM. The patient experienced chills, feeling feverish, aching left arm at injection site and exhaustion on 15Jan2021 at 16:45. On 16Jan2021, consumer stated, "I recently had the COVID vaccine and it was last Sunday. Is that possible to have a reaction 5 days out?" There was no treatment received for the events. The outcome of the events was not recovered.

I'm not sure if this is related; Was at work in out patient hospital facility and placed a mask on from a new box. I noticed my nose was itching a bit (I'm very sensitive to certain masks and usually air them out) A little while later I had an intense itching / prickly, sensation in my nose and started itching on my face under the mask. I took it off and found a different brand and took some benedryl. Seemed to get some relief and later that evening, I started to itch again including my head and inside ears, face had flushed with hive like rash. This continued throughout the weekend on and off eventually my whole body was randomly itching/tingly. No problems breathing. Took allergy meds and felt good but noticeably annoying. Called our covid info line on Monday and they gave me a few numbers for allergists. Mine retired. Had an appointment Tuesday morning. Dr felt it probably was reaction to mask not vaccine. Did a patch test with a piece of mask and did itch some but had a reaction to the tape that held the piece of mask in place so results not good. Took medrol dose pack and increased allergy meds. Still itching on and off randomly all over body, not as severe Delaying second vaccine by a week or two until this resolves per DR

Sore at injection site (felt like bruise); Sore at injection site (felt like bruise); This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in the right arm on 16Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included asthma/allergies and eggplant/zucchini sensitivity. The patient's concomitant medications were not reported. The patient experienced sore at injection site (felt like bruise) on 17Jan2021 that lasted approximately 36 hrs. The patient was okay by 18Jan2021 afternoon. Outcome of the events was reported as recovered on 18Jan2021. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior vaccination and has not tested for COVID-19 post vaccination.

very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.

FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES

C/O "TINGLING PIN PRICKS" WITH SLIGHT ITCHING SENSATION, NO SOB, NO HEADACHES B/P 136/100 SYMPTOMS SUBSIDED 10 MIN. LATER

Redness numbness and tingling in both hands Increases when hands are pointed down improves when lifted above the heart Is lessening but is clearly not listed as a side effect It is improving however is concerning more information and direction needs to be addressed several other coworkers have experienced or went to the ED with the same adverse effect. It is clearly not life threatening but I hope it will not increase with the second dose or continue in the future

woke up at 3 am with itching to her chest and arms; This is a spontaneous report from a contactable other health professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231), via an unspecified route of administration in the left arm on 18Jan2021 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included "hypothyroid", HTN (hypertension) and allergy to contrast dyes. The patient has been diagnosed with COVID-19 on an unspecified date prior vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included thyroid (ARMOUR THYROID), silybum marianum (MILK THISTLE), magnesium chloride and unspecified BP medications. The patient previously took tetanus toxoid and experienced allergies. On 19Jan2021, the patient woke up at 3 am with itching to her chest and arms. Patient took generic Zyrtec as treatment to the event. Outcome of event was recovering. The events were considered as non-serious. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Rash was reported as worsened.; she has developed a rash all over her face, arm, chest, and belly; The rash is just red, raised, and itchy; The rash is just red, raised, and itchy; This is a spontaneous report from a contactable Nurse (patient). The 61-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3248, Expiry Date: 01Apr2021), unknown in right deltoid on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Patient History: No. No allergies. There were no concomitant medications. The Caller, an LPN, reporting on the COVID 19 Vaccine and who explains she had it on 13Jan2021. Starting Friday into the weekend and through today she has developed a rash all over her face, arm, chest, and belly on 18Jan2021. The only thing that she can figure is the injection. She was told to call and report this. There has been no treatment, due to the holiday everything is closed. The rash is just red, raised, and itchy and driving her crazy. It is not anything too terrible, just uncomfortable. Rash was reported as worsened. No visit to emergency room or physician office. The outcome of the event condition aggravated was unknown and was not recovered or the rest events. No follow-up attempts possible. No further information expected.

Day 1 After - overall body aches Day 2 After- no ill effects until evening - noticed red rash on upper torso (front and some on back) Not itchy. No medical attention sought Day 3 After - rash persists and has spread to entire torso - front (Today is day 3)

Itchy rash on bilateral elbow; This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via intramuscular route of administration on 08Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Jan2021, the patient experienced itchy rash on bilateral elbow. The patient did not receive any treatment for the reported event. The patient was not pregnant at the time of vaccination. The outcome of the event was recovering.

Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad headache started while driving home. Took Tylenol but 24 hours later still have headache. Arm hurts at injection site. Very tired. slept 14 hours and still tired. Temp has been around 99.5 when I've been awake enough to take it.

I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day

facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.

Thyroid levels change meds changed to 50 mcg, red dots all over on torso, both back sides left , right. front breast right one , lower stomach area right, left. Emergency room doctor took photographs.

Fever,chills and uncontrollable shaking. Lymph nodes enlarged. Under layers of bedding and couldn't get warm. Fever got up to 102.5 on that Saturday about 25 hours after vaccine. Also, felt weak and very tired. Early Sunday morning about 2am, I woke up to my gown dripping wet from sweating. I changed went back to sleep and woke up again about 7am to the same thing. I did take Tylenol and Ibuprofen for the fever. I spent all Sunday in bed, no more shaking but chills and Fever persisted through out the day. Monday, I felt better initially until about 8 pm and symptoms started all over but harsher because know my Lymphedema flared up

Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough

Slight redness, slight swelling, and rash around the shot site. Applied benadryl cream for the itching. Resolved within 24 hrs.

pt stated about 10 minutes after rcvg vax she started feeling funny, warm and her heart was racing. She was checked out by the attending nurse at the vaccine facility. Her pulse was 120 and BP was 189/89. Pt drank a bottle of water while her pulse came down. About 5 minutes later her heart was racing again and BP back up. She was monitored for additional 15 minutes. During this time she had another episode with the same symptoms so she was rushed to the ER. Her heart rate was 110 and blood pressure still 189/? She was monitored for about an hour and 20 minutes. Pt was released from ER about and 1 1/2 ago and has not had another episode so far. She was told to FU w/ PCP in 2-3 days.

Patient reports feeling unwell after injection. She felt like "throat was swollen." Also reports having nausea/vomiting, fatigue and headache that persisted until 2/9/2021 (approximately 2-3 days after injection). She did not eat Saturday and Sunday (day of the injection and day after injection). She was finally feeling able to eat on 2/9/2021. She also reported sensation of heart going "fast" up to 93 on Sunday (2/7/2021). She denies any fevers or diarrhea. She also developed soreness in left arm at area of injection site, but did not have any redness at injection site.

6:00 am next day woke with a really bad backache hard to walk or bend or pick up something. Felt like that all day...very hard and stiff near back middle rib area both sides. Felt better if rested but if got up bad again. Very uncomfortable continued until the following morning. Got up today am 2/14 feel a lot better but slightly still there. Also had lymph node swelled a little in same arm as shot under collarbone. Hopefully my back isn't as bad as yesterday. Had to lay in bed a lot 2/13.

I received the first vaccination of pfizer at 10:00am Friday, February 12, 2021. I felt fine most of the day, only right arm hurt at the site of the vaccination. Then around 7:00pm at night the right side of my nose went numb, as the night went on, the right side of my mouth was numb. No changes upon waking Saturday morning. As the day went on the numbness subsided on the nose and mouth and moved down onto my chin. Today Sunday, very little numbness on nose and mouth, some on chin. Site of vaccine feels fine.

Rash/hives, itchy, hot Moved to various places over my body with each night getting worse for 3 nights. The first night I thought bug bites or maybe touched a plant and had a reaction. Went to doctor on Thursday 2/11 thought may I had may developed shingles but they said it wasn?t shingles. My husband took pictures because it would come and go. They prescribed 25 mg of hydroxyzine and I took one pill that evening and things have been fine since then. I haven?t changed anything else.

On February 4, 2021, I started to itch and feel like pins were sticking me on the front of my neck under my chin. On February 5, 2021 I started taking benedryl 25mg to combat the itching. By February 8, I had a fine rash, small raised all around my neck and very itchy and again I took benadryl without improvement. Benadryl would have a short term effect and just made me sleepy. This continued for 3 more days until February 15 when I was able to see my doctor who has now listed me as having a reaction and allergic to the Covid 19 Vaccine. I am prescribed topical steroid cream and hopefully it will improve.

Developed generalized rash over body, more pronounced on knees and lower legs. Rash remains now but is lighter. Significant L knee pain.

Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have

Having pain and burning sensation to skin at injection site of left shoulder. It radiates to the base of the head, posterior left shoulder and upper arm. Took one dose of Excedrin with temporary relief.

Pt stated itchy and swelling face at the time of her first vaccine, She did not report this at the time of the 1st dose and took benadryl when she returned home. Upon receipt of her 2nd dose, she notified the vaccinator, the medical OIC was notified. Benedryl was administered prior to onset of symptoms. Pt was instructed to be observed for 30 mins and observation was notified.

Numerous tiny white bumps on both legs only that were somewhat itchy & disappeared completely after 4 days; no treatment given

I want to report to Pharmacy and/or CDC what I have experienced with both shots (separate arms). In both cases, my upper shoulders into my neck hurt and tighten the day after the shot. The following day it was gone but it returned on or around day 4 and it has not gone away. I have seen my medical doctor, acupuncturist, chiropractor and a massage therapist. My doctor believes the shot activated some sort of chemical tendonitis. I took my second shot last Friday, in the other arm hoping it was simply coincidental, but I am having the same experience. I wanted to know who I should call to report this and was curious if anyone else has experienced this challenge. Thank you.

2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10:50am, Temp 100.3F at 5:15pm Temp 101.3F at 9:10pm and took tylenol and regular medications, Temp 100.6F at 10:55pm and went to sleep. 2/11/21: woke up with temp 98.7 at 10:00am, had body aches, red and feverish area where vaccine was given in upper left arm. The red, itchy and feverish area about 3 inches x 2 inches on upper left arm lasted about 5 days, also got a lump under left arm that lasted about 6 days and all of these went away by 2/17/21. But I've had more fatigue, and shortness of breath since this 2nd vaccine. Misses my doctor appointment on 2.17/21 due to the winter storm, not going anywhere , we were having all last week.

Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.

I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an hour and I got up I couldn't remember names of anyone, went to hospital to rule out stroke. EEG and double echo both normal. MRA and MRI, no evidence of stroke, transient global amnesia, it took a couple hours for me to get back to normal. I also had a shingles outbreak 10 days post both vaccines.

Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.

Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My lymph nodes right neck is swollen, also painful mass around 2x3cm below right clavicle near the sternum. I also have flu-like symptoms, body weakness especially lower extremities. Rashes and itchiness upper chest still present. 2/9/21 : Lymph node swelling of right neck & below right scapula still present. Rashes & itchiness upper chest still present but controlled with hydroxyzine tablet. Flu-like symptoms still present. 2/11/21: Rashes & itchiness minimal, less medication needed. Lymph node swelling less, still gets tired easily. 2/19/21: lymph node below right clavicle bigger for 1 day. No more lymph node swelling right neck. Still gets tired easily. 2/24/2021: Lymph node below right clavicle 1x1 in size, not painful.

chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.

Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.

About 10 minutes after receiving the vaccine, patient reported feeling somewhat short of breath and itchy. She presented to the clinic somewhat short of breath because of her asthma, but the itching was completely new. Gave the patient an age appropriate dose of Benadryl and symptoms resided within 15-20 additional minutes of observation time.

Eyes bloodshot; Rash over entire body...arms, legs, abdomen, back, neck; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 20Jan2021 07:45 at single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (WP THYROID), methocarbamol, and paracetamol (TYLENOL). The patient has known allergies to cefalexin (KEFLEX) and statins. The patient was previously vaccinated with the first dose of BNT162B2 on 06Jan2021 07:45 at the age of 61-year-old intramuscular at the right arm for COVID-19 immunization. The patient experiences rash over entire body, arms, legs, abdomen, back, neck, not on the face yet and eyes bloodshot; symptoms appeared over 8-hour period beginning at 7 am on 26Jan2021. The patient did not receive any treatment for the events. The outcome of the events rash over entire body and eye bloodshot were not recovered.

Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.

Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 had a Shingles rash for which I consulted a dr and was treated

Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:00pm. Itching stopped 2/28 however the rash is still present on 3/2. Took Benadryl.

rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.

numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling strange; she had itchiness to her right hand; started to develop hives; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Feb2021 at 09:00 (at the age of 61-years-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives on 01Feb2021. The clinical course was reported as follows: Approximately 3 hours after receiving the vaccine, the patient started to experience numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, and she had itchiness to her right hand and started to develop hives. The patient stated that she cannot take diphenhydramine hydrochloride (BENADRYL), but she did take cetirizine hydrochloride (ZYRTEC) to help with the symptoms. The patient was still having symptoms at the time of reporting. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!

At 0900 this morning my face next to the right side of my mouth started itching. I immediately felt it swell. I looked in the mirror and could see the left lower part of my face (lower cheek by the edge of my mouth) swell and my right upper lip started to swell. I took a Benadryl (25mg oral tablet) and my roommate drove me to the Emergency Room. That area of my face continued to swell and impacted my lower lip as well. My lips were numb and tingling and I could feel my cheek swell more inside my mouth as it was touching my teeth. I was monitored (vital signs and pulse ox) for 90 minutes and received 20 mg of pepcid oral tablet and 10 mg dexamethasone oral tablet- both 1x only.

arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.

I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.

Hives on back of neck. Slightly itchy. Noticed a couple hours after vaccine. Noticed a bit more the next morning. Took Benadryl 3/7 night. No increase or decrease in hives noticed so far.

I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.

After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.

He received his 1st COVID-19 vaccine around January 24th and 30 minutes later developed mild lip edema, itching of the skin Nose and ears. A day after injection patient had Benign fasciculations

Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.

One week after receiving the vaccine, my arm began to swell at the injection site. Today it?s larger, about the size of a tennis ball and it?s warm to the touch. It?s also a little red. It does not hurt.

Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: itchiness at site of injection, mild

Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccine and Headache. I felt tired and rested around 1:00p.m. Took 1 extra Strength Tylenol. Then started getting chills. Felt like I had swollen lymph node on ride side of throat when swallowing and had some pain going up into my ride ear. These symptoms lasted all evening. I didn't feel like eating dinner so rested and took 2 extra strength Tylenol at 9:00 p.m. and went to bed. Woke up early in morning with bad headache so I took another 2 extra strength Tylenol around 6:00am. I finally started feeling better around 9:00am.

Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.

Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell

Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.

Developed a rash near my eye after a couple of days rash moved to my face and neck. After the second shot rash covered face, neck and face and eyes would be swollen

8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities. Lasts hours at a time and changes location. Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.

Patient was sitting in monitoring area status post covid vaccine injection (Pfizer 0.3mL). Patient complained of flushing, erythema noted on anterior neck and chest, and hive was observed. Patient denied shortness of breath. BP 132/92, HR 90, Pulse ox 98% room air. Benadryl (Lot #080012, exp. 08/2022) was administered 50 mg/IM per order into left deltoid @ 1337. EMS was called per protocol. 1340- Vital signs were 156/110, HR 84, pulse ox 98%. 1342- EMS arrived- VS 162/110, HR 85, pulse ox 98%. Patient then complained of feeling lightheaded. Patient was transported to ED without further incident

Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting stiff. It felt like the stiffness was creeping up my neck. After about a hour I felt my ear lobes tingling and the left side of my face in the jaw area seemed a bit swollen and felt a little numb. It resolved and I had only a sore injection site the next day and no other symptoms. I'm wondering if I should be concerned about getting the second shot

Swelling/pain in Left deltoid at injection site; Mild frontal headache; Fatigue 4 hours after vaccine Mild frontal headache; Swelling/pain in Left deltoid at injection site; This is a spontaneous report from a contactable nurse (patient). A 61-year-old non-pregnant female patient received BNT162B2 (solution for injection; lot number: EL9264) in left arm, via an unspecified route of administration on 09Feb2021 09:30 am at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included osteopenia, mild depression. The patient had no known drug allergies. The patient concomitant medications included citalopram, ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+). The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient experienced Swelling/ pain Left deltoid at injection site, fatigue 4 hours after vaccine, mild frontal headache on 09Feb2021 13:00. The patient did not receive treatment for the events. Outcome of vaccination site swelling and pain was recovered on an unspecified date of 2021 and rest of the events was unknown.

nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.

Developed skin rash within hours of receiving vaccine, started on the forehead and spread down the face including the ears and eyelids, a more mild rash on the arms, legs and stomach. took some Benadryl which help with the rash. rash lasted about 4 to 5 days.

bruise to her back; rash on back of neck/rash all over her body; redness; swollen area back of neck/ swollen area to her back; a lot itchier; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via intramuscular on left deltoid on 21Jan2021 at 14:00 at single dose to prevent Covid 19. The relevant medical history included obese from an unspecified date. Concomitant medications were reported as none. The patient experienced rash on back of neck/rash all over her body on 26Jan2021 at 19:30, swollen area back of neck/ swollen area to her back on 26Jan2021 at 10:00, redness on 26Jan2021 at 19:30, bruise to her back on 27Jan2021 at 10:00, a lot itchier in Jan2021. The nurse stated that she wanted to report that she had the Pfizer vaccine last Thursday. Stated that two days prior to the report that a rash started on the back of her neck and stated yesterday it was a lot itchier (as reported). Stated that she got undressed to put her PJs on and noticed that she had a fine raised rash everywhere and it was swollen. Stated that she went through her house to see if there was anything that could have caused it. Stated that she went to that doctor at the time of the report and was started on Prednisone taper. Stated that the doctor was concerned about the Prednisone reducing her ability to prevent antibodies. Stated that the doctor stated that he was unsure if she should get the second dose. Caller wanted to ask questions about these things. Had not started the Prednisone yet. Stated that there was redness to the back of her neck and back. Stated that the swelling was to the back of her neck and back. The events did not require a visit to Emergency Room but required a visit to Physician Office. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The event bruise to her back was reported as non-serious, while the events rash on back of neck/rash all over her body, swollen area back of neck/ swollen area to her back and redness were reported as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "rash on back of neck/rash all over her body", "swollen area back of neck/ swollen area to her back and redness" and the administration of the COVID-19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Large raised red area at injection site started the day after injection and it has now been 8 days and it is still there and itching and warm to touch

Immeditely after my first shot on March 7 I felt fine (except some mild soreness at injection site). A full week later, on March 14, I had some mild chills, fatigue, headache, and a red itchy rash. The rash was located on my right inner forearm, my left inner thigh, my lower back and hip area, and my ears. No rash on injextion site arm. I took benadryl and used a topical 1% hydrocortisone cream, and the rash eventually subsided after 5 days.

I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow (injection was in left arm), and nausea. Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night. Symptoms continued until morning of March 20, 2021 and gradually lessened by evening. Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache. Ate a few saltine crackers to lessen nausea symptoms & drank ice water. Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.

After taking a hot bath. Redness at vaccine site and down the left arm on both sides. Some itchiness at the vaccine site. Took 1 benadryl and the redness and itchiness disappeared rather quickly. Some mild redness at the site.

Patient received the Covid-19 vaccine. She reports symptoms of sudden onset itching throughout entire body 5 minutes post-injection along with sudden onset severe headache. Vaccine injection time 1715, symptom onset at 1720. Vitals: @1720: BP 148/94, HR 79, O2 98 @1725: BP 148/83, HR 80, O2 99 (PO benadryl 50mg given at this time) @1730: BP147/80, HR 70, O2 96 @1735: BP 148/82, HR 71, O2 99 @1745: 149/92, HR 74, O2 98 @1755: BP 148/71, HR 73, O2 97 @1805: patient ambulated to restroom. Patient stated that "symptoms aren't improving at all after benadryl -- I think I should go to the emergency room. Wait until I get back from the bathroom to call 911." @1814: Patient returned from restroom, 911 called @1820: EMS arrived, care handed off to EMS @1825: EMS transported patient to ER

Patient stated that approx. 5mins after getting the vaccine, she felt very nauseous and had full body itchiness. 50mg of PO Benadryl was given prior to coming to the hospital. Patient arrived at hospital & still complained of itchiness. Pt received solumedrol & Pepcid IV.

A very itchy rash which looked like shingles about 5 inches in diameter appeared under my right arm close to my breast on Sat. About 30 mins. later it began to look like large welts. About 30 mins. after that it disappeared leaving raised skin. The raised skin went away in about 30 mins.

Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone

Rash on my abdomen and arms started about 5 days after the vaccine. Rash is itchy and looks like raised bug bites. Itching mostly at night. Will break out in different areas on arms from day to day. Abdominal rash remains constant. Started using OTC cortisone to minimize the itch and started taking Zyrtec for the itch. It still remains as of this report and hasn't gotten any better.

On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.

very large red rash at the injection site; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL9265), via an unspecified route of administration in the left arm on 29Jan2021 1:00 PM a single dose for COVID-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any other vaccines in four weeks prior to receiving BNT162B2. The patient was not pregnant. Medical history included seizure disorder. The patient did not have covid prior to vaccination. She had no known allergies. On 06Feb2021, the patient had a very large red rash at the injection site 8 days after vaccination. It was not particularly itchy or uncomfortable. It seemed notable only because it was over a week later. The patient did not receive any corrective treatment for the event. Outcome of the event was recovered on an unspecified date. The patient was not tested for covid post vaccination.

Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.

Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).

Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills, headache, muscle aches, sore throat, joint pain that lasted until Tuesday morning, March 16th. I had no symptoms on Tuesday & Wednesday, but developed hives on my ankles Thursday afternoon exactly one week after the Covid 19 vaccine. When I got up Friday morning I was covered in hives on my legs, arms and abdomen. The whelps were raised and itchy and appeared to be spreading. I went to my HCP and they administered an intramuscular steroid shot and advised me to take Benadryl as needed

Patient received vaccine Saturday morning 3/20/21. She stated she woke up on Sunday morning 3/21/21 and had a "rash on her arms and chest, and some of the spots looked like blisters." She went to her dermatologist on Wednesday 3/24/21, but they did not give her medication for treatment. Patient states that the rash is improving.

BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.

I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. Being a nurse I thought I was breaking out as the days went by I noticed it was Shingles.

Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.

Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site no redness, warmth. Patient expressed both parents recently passed away and expressed increased anxiety. Pt walked to the car, steady and stable. Pt will take tylenol as prescribed, rest, and hydrate. Recommend pt to follow-up with PCP on Monday for anxiety and elevated BPs. Pt denied HTN. Vitals: At 13:25, 160/82. 1 minute after 99 At 13:45, 160/82, 98HR, 99% spo2.

Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on leg started to get worse, leaking a lot of fluid; back is hurting; felt like a tetanus shot in her arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809), intramuscular in left arm on 10Feb2021 14:30 at single dose for covid-19 immunization. Medical history included high blood pressure, rheumatoid arthritis and kidney issues. Concomitant medication included insulin. The patient had the first COVID-19 vaccine. She had a lot of issues wrong with her, however she did not have them hit her at the same time. It was currently the 9th day since she had her first shot. About 4 or 5 days into it, the wound on her leg started to get worse. She had rheumatoid arthritis and she had an RA attack. She had herpes, but she did not had an outbreak in a couple of years. She got blisters in her mouth, and this also hit her. She explained everything hit her all at once. She was now on antibiotics for each one of the things. Her doctor figured out that her body just couldn't handle it. She clarified putting the vaccine into her body, she couldnt fight off everything. Like whatever in in the vaccine and how the vaccines works, her body was just not strong enough to fight off everything at the same time. The patient did not went to the emergency room. It was reported that the patient would receive her second dose on 03Mar2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.

Severe itching all over, anaphylactic, took two allergy pills and medical test on music related to the nostril shot of Flonase

3/23 mild headache 3/24 mild headache 3/25 mild headache 3/26 rash started, in patches, right arm, trunk, under hair on head, and partially down back of neck.Severe itchiness. Took OTC benadryl, two tablets, no relief. 3/27 rash continues, itches more in evening

Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.

Beginning around 8:00 pm I felt prickly all over my body. Not severe, but uncomfortable. I believe I also developed a minor rash. I took benadryl that night and slept fine. I felt the same way on 3/23/21 and took benedryl again. It seemed better 3/24/21 but came back on 3/25/21 and has continued today 3/27/21. After a walk outside with no jacket it is feeling better, but I can tell it's still there. Called my doctor on 3/23/21 and she recommended benadryl at night and allegra or claritin during the day. And ibuprofen and pepcid. I only have taken the benadryl. She advised not getting the second shot.

Complaint of itching beginning on face and all over body within 25 minutes of receiving vaccine. Hive-like rash to back present. Patient was given Benadryl 50 mg IM per Nurse Practitioner order and symptoms began to resolve within 10 minute with complete resolution within 30 minutes. Patient left clinic with family member and was advised to contact emergency care or physician if symptoms return.

Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, intermittent fever, loss of appetite

Approximately 25 minutes after receiving the vaccine I noticed my eyes were beginning to itch and my throat felt odd and was accompanied by a hoarse voice. I was driving home at that point and considered turning back for medical advice (should have but did not). Over the next few hours itching sensation on my tongue, face including eyes, head and back. Developed just one hive on my eyebrow approx 3 hours after vaccination, and one on my thigh at least six hours after vaccination. The symptoms were not severe but obviously I monitored them. Now 24 hours after the vaccination and still have some itching as described above. Throat is somewhat better. Eyes feel odd more than itchy at this point.

The following morning after the shot I woke up with 5 large, itchy hives on the right side of my abdomen - almost like large mosquito bites. A couple of hours later I got one more closer to the center of my abdomen. I don?t know if this is related or not. I used hydrocortisone creme on the areas.

24 hours later I developed a "black eye" on the right eye. No swelling. No tenderness. Just a very dark purple black bruise appeared on right eye in the inner corner.

Injection site pain, tiredness, headache, bodyaches, nausea, feeling unwell, loose bowels ( not diarrhea ), minor congestion

Mild asthma flare and mild itch on face 60-90 minutes after injection. Symptoms resolved with no medical treatment required.

Severe itching, swelling just below the injection site for over a week. Scratching it made it worse until the swelling went away. I used anti-itch remedies to help. Skin is discolored.

Once injection given, felt like Electric shock immediately afterwards, bleed a little, area swelled, painful and turned a purple /black. The next day my neck, shoulder and area where injected swelled and painful. Muscles aches all over. After about 3-4 days leg muscles stopped hurting but muscles in left arm continue to be bothersome, from my shoulder down to my thumb muscle spasms throughout the day. To this day 3/29/21 I continue to have muscle spasms from my shoulder down my left arm.

pain / swollen area where injection given. joint pain in every joint in my body - never had this before vaccine. Facial muscel spasms; both eyes and left side of cheek area. Never had this before.

I had an odd reaction. Approx 20min (on my way home), after the jab I began to experience tingling at the injection site (left arm) that traveled down my arm, up to my shoulder, neck, jaw, then down the entire left side of my body. This lasted most of the day. ( an hour later also felt 30min of same in my right arm elbow-hand that on lasted 20min.) Lots of fatigue for first 3 days. My neck/jaw still feels faintly like novocaine wearing off. Right now (1 week post 1st vaccine) I'm feeling coolness in left side of body & right arm from elbow to hand. It began in left side of neck. (Very weird. I've never experienced anything like it before.) I've no pain in neck, or any cervical spine issues. I do have L5 degeneration, but it's not painful (yet...) Brain-related? Do I take 2nd dose or switch to J&J at 4 weeks? Id' love to hear from someone. I've contacted Pfizer, but haven't heard back.

2nd day: Soreness of injection site 3rd day: Soreness of injection site with swelling at site 4th day: Soreness with sensitivity to touch throughout the upper part of the arm 5th day: Severe pain throughout the arm. Numbness in my fingers. light headiness, passed out for a few second. light tremors.

Dizzy about an hour later. Worked through it. Itching/swelling as in first dose in arm but handled with anti-itch sprays and cremes. In afternoon, nauseated and dry heaves. After 9:00PM, high fever, aches, constant chills throughout the night. Extreme thirst. Fever through the next day and used a COVID sick day. Symptoms gone by morning of 03/27/2021.

Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".

Very painful lump in fat tissue starting next morning. Red spot starting that evening, gradually growing for 4 days. Hot, hard lump and redness still present after 5 days. No irritation/ pain in muscle at all this time. Lump and pain localized in fat tissue only.

Body aches; Sore injection site; Nausea; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 09Feb2021 15:30 as Single Dose for covid-19 immunisation. Medical history included drug hypersensitivity (Sulfa allergy), thyroid disorder and hypertension from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, liothyronine (NP THYROID) from unspecified date to unspecified date for unknown indication. On 09Feb2021 23:00, The patient experienced body aches, sore injection site and nausea. The action taken in response to the events for BNT162B2 was not applicable. Outcome of events was not recovered.

Nurse injected second Pfizer COVID-19 vaccine into injection site in right deltoid and immediately there was swelling to the size of a 50 cent piece. Area was skin color, no redness or heat or rash. Medical director assessed patient and patient was observed for 15 minutes. Area of swelling remained the same size.

Shortly after receiving vaccine experienced phantosmia - smell of perfume or soap. Worked 6 - 11 pm on 3/29/21. Arm very sore at bedtime. Woke up feeling very tired and weak with arm feeling even more sore. No redness or swelling at injection site. Feeling nausea, body aches and cough, called off work on 3/30/21 for 12 - 10 pm shift. Woke up 3/31/21 feeling lethargic with body aches, cough, still smelling perfume and feeling need to suppress cough. Showered around 9 am and noticed rash developing on inside of right thigh and itchiness/rash under right side of jaw. Scheduled to work 5:30 - 10:30 pm this evening. Will attempt to attend work.

Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we gave 50mg of Diphenhydramine orally, patient condition worsened, she described her throat starting to swell up, and had noticeable difficulty breathing and shortness of breath. We administered Epinephrine at 10:55am and within 5 seconds patient reported improvement. Patient remained stable until EMS arrived about 5-10 minutes later. Patient was advised to be taken to the hospital for monitoring and agreed. She remained stable and reported an "itchy back" upon exit.

Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.

chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth. The patient's concomitant included an unspecified medication (she takes something but not relevant). The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

Bad chills; body aches; extreme tiredness; Some injection site soreness; Bounced off a headache at times; This is a spontaneous report from a contactable other health care professional. A 61-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in left arm at the age of 61-years (non-pregnant at the time of vaccination), on 10Feb2021 at 11:45 AM at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and ascorbic acid, colecalciferol, nicotinamide, panthenol, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine hydrochloride tocopheryl acetate (MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]) at an unknown dose, daily. The patient previously took doxycycline and amoxicillin and experienced drug allergy with both the drugs. The patient previously took first dose of bnt162b2 (Lot number: EL3249), via an unspecified route of administration in left arm at the age of 61-years (non-pregnant at the time of vaccination) on 20Jan2021 at 11:45 AM for COVID-19 immunisation. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced bad chills, body aches, extreme tiredness, some injection site soreness and bounced off a headache at times on 10Feb2021 at 09:15 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID.

Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available

I have had symptoms that mimic Breast Cancer Nipple discarge Nipple redness Lymph Node Pain Swelling Discomfort

The night I got the vaccine, I woke up with a terrible headache and body ache. I just didn't feel well. I tried to work the next day ( I work from home) I kept having to take little naps. I started shivering and I had a fever. Towards the end of the day I had to go to sleep. My fever got as high as 101.9- lasted about 24 hours. After the 25 hours the fever went away but had shivers still. I had welts on my arm where I had gotten the shot, it was red and warm. He circled the area and went to sleep in the morning it was larger. I went to the Dr. and he looked at it and pit me on a antibiotic for cellulitis. That eventually resolved and got better.

2 hours after getting the vaccine itching began on stomach, face, legs and arm. I took an antihistamine and it subsided.

I noticed a rash above my left ankle on the inside of my leg on 3/30/2021 in the morning. It was red, but not itchy. On 3/31/2021, it had grown larger and redder, but still did not itch. I am treating the rash with a topical cream containing colloidal oatmeal. I am not prone to rashes or hives. The size of the rash is approximately 4 long by 2 inches deep. I have not been seen by a medical professional.

Feeling of heat in mouth, numbness in mouth, swelling in throat (not severe), difficulty swallowing (not severe), tongue swelling, Day 3 post injection: hives on upper left arm just above elbow, Day 4: headache (severe), numbness/tingling in jaw, neck and face, swelling of lower legs.

11 hours after?intense shivering shuddering 22 hours after, awoke to?shivering, sweating, dizziness, lightheadedness, inability to get out of bed, dry heaves 23 hours after?attempted to get out of bed, fell/collapsed/fainted sustained many bruises

Left arm started to hurt minutes after the injection, radiating down toward elbow and my arm started to go numb, especially the pinkie and ring finger. Difficult to hold my phone while waiting, I dropped it, then started to get dizzy. Called a volunteer over, who summoned another lady. They told me they were going to move me to another area, and attempted to help me there, but I fainted about 3 steps out. When they were lying me down on the floor, I came to and was oriented at that point. BP was somewhat low initially, but increased as I lay there, and oxygen levels increased from 94 to 99 before I left facility.

pt states her arm felt like it was on fire as the vaccine was being administered. She became very dizzy and had a headache. On 3/16/21 her arm was sore at the injection site. Her throat hurt and when she swallowed she would have a sharp pain right between her eyes. Her left arm became very painful and every time she tried to move it would cause pain in her chest. She had diarrhea, sweating and had 101 fever. On 3/17/21 she had to have someone help her our of bed on this day. She felt like she was going to pass out. She had this feeling on at least 3 occasions. Pt had pain when opening her eyes, trouble breathing and having heart palpitations. She called her cardiologist with her symptoms and was told it was related to taking the vax. She had a televisit w/ PCP and she was sent to have a Covid test which was negative. She was told to drink plenty of fluids and rest. By 3/20/221 pt started feeling better at this time.

Woozy, felt like body was swelling, then numb, then tingling, then like a rag doll. Headache, nauseous. Red rash all over face. Very fatigued. Most of it lasted all day.. Next day, Friday, still very fatigued and a slight headache that comes and goes. Everything else was gone. Had no problems with breathing. No fever. Had no treatment.

The rash began as a faint red macular rash below the knee on the left leg before progressively spreading and involving the contralateral leg, lower abdomen, and bilateral upper extremities. The rash was mildly painful but not pruritic. She was otherwise asymptomatic. On examination, the patient was afebrile and well appearing. There was erythematous to violaceous palpable purpura scattered on the lower abdomen, lower legs extending to the feet, and forearms extending to the palmar hands. The lower extremities had several dusky violaceous vesicles, some with superficial erosions. Punch biopsy confirmed Leukocytoclastic vasculitis. She was treated with topical corticosteroids and rash is still resolving.

Hives, given Prednisone by physician a week later could not get appt same week, after tkaing prednisone Hives diminished. I not have the hives back periodically. I have had hives before due to the Auto Immune but they were under control for 3 years. Now I am back to where i was years ago

Nerve pain in two molars (upper and lower) on left side. Earlier symptoms included pain at injection site, soreness of arm, headaches, and tiredness.

Pain and swelling ("knot" at vaccination site in left arm muscle); extreme fatigue; headache; nausea; gastrointestinal issues (upset stomach; diarrhea; loose bowels); and lack of appetite.

arm soreness at injection site (both vaccines); This is a spontaneous report from a contactable Other HCP (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL0140), via an Intramuscular route of administration on left arm on 28Dec2020 12:00 at single dose for Covid-19 immunization administered at Hospital. The patient medical history included hypothyroidism and hyperlipidemia. Concomitant medication in two weeks of vaccination were not reported. No Allergies to medications, food, or other products was reported. The patient reported, arm soreness at injection site on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, the patient underwent lab test SARS-CoV-2 test Nasal Swab result-negative. The outcome of event was recovered.

development of rash on both arms, torso, side of face, right hand - redness, swelling, terrible itching

Approximately 2 1/2 hours after getting the vaccine my entire body starting itching (mild) and my cheeks were bright red and hot. This lasted approximately 8-10 hours after onset and then cleared up.

2 days after vaccine elevated heart rate and elevated blood pressure.By March 25 head to toe all over constant itch.I am trying different antihistamines at this time.

swollen ankles noticed at bedtime when removing shoes, slept & woke up normal, after 3 hrs being up swelling again (but less) the following day no swelling, but noticed rash on stomach that lasted 2 days then was normal.

Hives around neck and different locations on upper body. Lasted two days. Took pharmacist recommended Benadryl.

Her face started swelling and turned red and her throat felt tight.. She was given .3 cc of epinephrine . She felt better then we had to repeat the dose in about 15 more minutes. She could still breath easily but she did not feel better after the second epinephrine shot. She was sent to the ER in an ambulance

I DEVELOPED SOME SORT OF RASH OR HIVES ON MY UPPER CHEST, BUT IT DOESN'T ITCH. THERE ARE 2 SPOTS NEXT TO EACH OTHER. ONE IS ABOUT 2x2 INCHES, AND THE OTHER IS ABOUT HALF ITS SIZE. I FIRST NOTICED IT 5 DAYS AFTER HAVING MY FIRST VACCINE DOSE.

Rash started about 8 days after injection ? located on both arms, chest and neck. I inquired with my pharmacist about whether it could be a reaction to medicine I was taking. He didn?t think it was since I?ve taking that since December 2020. He mentioned I might want to report it.

High fever for 2 night in a row (in excess of 103), nausea, headache, sore muscles and joints, sore teeth, red inflamed area of vaccination about the size of an orange lasting 5 days., dizziness, unproductive cough, extreme tiredness for 3 days and lingering for 5 days.

continual ain-discomfort at the injection site, pain lifting the left arm including the shoulder. no visible bruising.

Injection site swelling, redness, pain, itching, headache, tiredness, chills, fever, nausea, feeling unwell, difficulty breathing, weakness

440, Pt arrives in observation, approx 5 min after receiving vaccine, observed sitting in chair comfortably, no apparent distress, no cough observed at this time, skin appears dry, appropriate skin color, no s/s increased respiratory effort, Smiling playing games on phone, denies any discomfort at this time. 500- Observed pt with intermittent dry cough Pt describes as "just a little tickle", lips pink (mask removed temporaily), talking without difficulty. Denies distress, Offered water, no obvious increased respiratory effort. Pt agrees to continued observation, Offered water, appears to be swallowing without difficulty. 5:05 pt reports "harder to talk without cough" observed increase in frequency of dry cough, pt reports that she wants to continue to be observed, does not want benadryl at this time. Pt agrees to plan that includes, if she feels worse, she will be offered benadryl, she agrees, that if she does receive benadry, she will not attempt to drive herself home.She reports that benadryl "makes me drowsy"She agrees to call family to have them come pick her up. Lead RN at pt;s side. 510- increased frequency in coughing, pt reports that "it's harder to talk without coughing, itchiness in throat increasing" she denies shortness of breath, but reports that she is concerned that she will become short of breath, therefore agrees to 50mg benadryl IM (r deltoid), still awaiting family arrival. Pt reports, "feel hot" No observed increase in respiratory Moved to bench couch(prior to recivng benadryl, , EMT present , vitals taken, bp 148/92,pulse=83, pulse ox 96-98%, pt reports that this BP reading is "higher than usual for me", denies pain except for pain at vaccine injection site, 5:20. No obvious change of status noted, skin remains pink, +cap refill, lungs cta no wheeze herd per EMT. 5:24- pt reports that she is "getting a little drowsy, but feeling better". Cough appears to be less frequent.Pt appears more relaxed, talking without effort, respirations appear to be without effort, relaxed.Conitues to agree not to drive herself home, awaiting her daughter to come get her and drive her home, Encouraged pt to have daughter come up to floor, did discuss with pt, although she is feeling better at this time, if she feels worse, once she is driven home by daughter, she will seek emergent care immediately. Pulse ox 98%, appears to be in no distress. Only occasional cough noted. 5:28, pt reports that she sees her daughter on floor and walks (with normal gait),towards a couple, went to offer to escort pt to car, but she walked away from couple, and left floor without coming back to observation. 5:30, pt observed (from 3rd floor window), talking to another adult woman presumptively her daughter, 5:35, pt observed (from 3rd floor window getting into a different car, by herself, sitting in drivers seat and drives off by herself, driving the car.

Began with soreness at the injection site and tiredness about 16hours post injection. Then I had body aches headache and low grade fever (99-100 degrees), about 18 hours after the injection. I had a rough night waking intermittently but all symptoms were gone when I woke at 10:30 am on 4/7/2021.

In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold.

In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As if this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday

Minor Outbreak of hives approximately 1 hour after the shot. Second outbreak of hives covering entire body on April 5, 2021

In order of occurrence: Chills/Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold. Note that after my shot I was out until about 4:30 pm. While out, I noticed that my face and neck felt hot and my neck was getting itchy, but I did not check it. After returning home, the itchiness, chills. etc. slowly increased until at 6:30 pm I was very

Arm soreness/pain impulses upon lifting of arm; pain about 10 minutes after injection; a fluttered feeling as if a fast heart rate; Difficulty lifting arm; This is a spontaneous report from a contactable nurse. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 16:00 (Batch/Lot Number: EL9262) as SINGLE DOSE for COVID-19 immunisation. Medical history included diabetes, HTN (hypertension), Elevated Cholesterol, glaucoma, GERD (gastroesophageal reflux disease) and Known Allergies: black pepper. The patient's concomitant medications were not reported. The patient previously took Flexeril, codeine and fentanyl for all these drugs experienced drug hypersensitivity. Initially a fluttered feeling as if a fast heart rate, but 60 second counts revealed pulse regular and no more than 80. Arm soreness; pain about 10 minutes after injection. Continued despite use of Tylenol and heat packs. Difficulty lifting arm; pain impulses upon lifting of arm on 23Jan2021 16:00. The patient underwent lab tests and procedures which included heart rate was 80/min. The outcome of the events was unknown.

Developed shingles after the first dose. Doctors do not believe it was related to the Pfizer shot. I am reporting it, just in case.

fever 100.6, nausea, injection site pain, joint pain, tired, chills, headache,muscle pain, sweating alot, sick dizzy & weak

tingly lips with bumps on the inside, itchy skin on scalp, soles of feet, neck & chest, and underpants region. -lasted 9hrs, then started again at 2AM on 04/08/2021 for about 45min. -was on & off for the day on both April 8 & April 9.

Chief Complaint rash History of Present Illness Rash on L back/hip x 1.5 weeks red bumps, at low back, buttock and back of thigh, last new lesion 2 days ago pain on the L thigh discomfort on the back of knee and back of thigh h/o shingles in 20's h/o zoster vaccine 2019 immunosuppressed for RA, PA no itchying still developing more spots no fever gardens but hasn't done anythign to trigger back/leg pain

Pfizer Covid-19 VAccine, mRNA, LNP-S, PF, 30 mcg / 0.3 mL dose. Carton, 195 Multi-dose vials. REACTIONS: Day #1 April 8th. Soreness, tenderness, mild headache, feeling unwell. Day #2: Very sore, tenderness, Headache, feel unwell. (Note: Was not able to lift my Left arm fully this day.) REDNESS at muscle injection site Did Not appear until Late evening, about 8pm on Day after vaccine given. Day #3 (date of this report): Still tender, Redness, Arm more mobile, able to lift up after late evening of Day #2. I'm taking MOTRIN IB tablets - 2 tablets every 8 hours. It was really for some slight nerve pain in my Rght thigh area, But ti has helped with Soreness, and diminished redness at injection site of the vaccine. RE: FACT SHEET for Pfizer Vaccine. Lists "Risks of Vaccine, Side Effeects.) Here is my List; Day #1: Injection site pain, tiredness, headache, muscle pain, feeling unwell. Day #2: Injection site pain; tiredness, headache, muscle pain, injection site Swelling, Injection Site Redness. Day#3: Site pain; Swelling , Redness.

fever, aches, joint pain, headache, nausea, chills, injection site pain up to shoulder, weakness, tired, diarrhea Took Tylenol to sleep, most symptoms lasted from lunch time to bed time. About 12 hours. Today, lingering tiredness, and aches.

Itchy on left arm and around mouth. Assessed and stood by with epi pen. Symptoms eased and patient returned to normal and released

Starting within 30 minutes of shot developed, rash and itchiness all over back. Itchiness in ears, throat and on scalp. Sore throat. Highly elevated BP - 190/100. Was given Benadryl 25mg and sent home. I slept for about 4 hours. Only very minor itching remained for about an additional hour. Minor sore throat continues (4/10/21 10:20 am)

back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient had the shot on the 09Mar2021 back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger. The outcome of the event was unknown. Information on batch number has been requested.

feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.

swelling of tongues and upper inside plate; upper inside palate in her mouth was also kind of swelling; upper lip tingling/numbness and swelling of tongues and upper inside plate; muscle soreness near the injection site; injection site was painful; couldn't move her arm behind her or up and was limited with that arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 22Mar2021 10:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included she was in generally good health besides being hard of hearing and she got hit by a car at age 2 and after she got older her HCP said she would be completely deaf by age 60 and she was now classified as being profoundly deaf. There were no concomitant medications. She had never gotten the flu shot in her life. The patient experienced had muscle soreness near the injection site, injection site was painful, couldn't move her arm behind her or up and was limited with that arm on 22Mar2021, numbness and swelling of tongues and upper inside plate, upper inside palate in her mouth was also kind of swelling and upper lip tingling, all on 22Mar2021 19:00.There was no treatment received. She had physician office visit to ask the HCP to see if there was anything she can take before she takes the 2nd dose to prevent this. The clinical course was reported as follows: She had the 1st dose of the Pfizer Vaccine on 22Mar2021 at 10:15am and for the most part where the injection site was and some in the muscle it was very painful and she was told this is very common; the vaccine was given in her left arm into the muscle and the injection site was painful for a while and then the muscle below it felt painful and throughout the day and yesterday she couldn't move her arm behind her or up and was limited with that arm on 22Mar2021. Today the pain was getting better and the muscle and injection site still are kind of sore but she was sure that would get better in time. Around 7:00pm(22Mar2021 19:00) in the evening she had another reaction that was not listed in the severe reactions and that was she had some numbness and swelling in her tongue and then the upper inside palate in her mouth was also kind of swelling and her upper lip was tingling; states this swelling and tingling began on 22Mar2021 and was not ongoing fortunately she slept sitting up and did not want to lie down and suffocate herself; when she woke up at 4:30am the swelling and tingling went away so she does not know what time the symptoms went away because she was asleep. She had no treatment and tries to avoid medicine as much as possible and did not go to the emergency room but following yesterday she went to the walk in clinic last night because she wanted to ask the HCP to see if there was anything she can take before she takes the 2nd dose to prevent this, and the HCP said there is nothing he can do. Case were assessed as non-serious by reporter. Outcome of muscle soreness near the injection site, injection site was painful, couldn't move her arm behind her or up and was limited with that arm was recovering, of other events was recovered in Mar2021. Information on lot/ batch number has been requested.

Mild head ache and lightheaded ness started within a few minutes. Fast heartbeat followed. After my 15 minute wait time before leaving, I told them my experience. They took my blood pressure which was 175 over something. They let me leave when it was down to 144 over something. Within a few minutes after we left I experienced a severe hot flash, my air cutoff, and I felt weak/faint. I experiencedy airways close, then open again. Nothing like I have experienced before with an asthma attack. This was different. My husband pulled over and I was able to call 911. My heart was racing. The paramedics asked me about the rash on my chest which I new nothing about until he mentioned it. Said my face was flushed? And

Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.

4/9/2021: mild headache, arm soreness, muscle aches, tiredness and chills beginning about 6pm. 4/10/2021: headache moderate, muscle aches and joint pain moderate; chills, tiredness, diarrhea beginning in the morning and ending early afternoon; 4/11/2021: woke at 5am because left arm (injection site) hurt; arm mildly swollen along with armpit lymph nodes in left arm, tiredness. 4/12 & 4/13: armpit lymph nodes still a little swollen and tender, arm tender, slight tiredness, other symptoms have resolved but lymph node swelling continues

Horrible headache and eye pain 1 day after second vaccine. On second day, Shingles developed on left forehead and scalp, and in left eye. 14 days PO Valtrex, zirgan opththalmic ointment 12 days, Lyrica, nortriptyline, Tylenol, Tramadol on-going. Still have slight rash with few new blisters everyday, burning/itching/tingling and fatigue.

Both of my legs in the front only was burning and itching to the point where I could not wear any thing over them . At night I could even let the covers touch my legs. At night it got 5 times worse. It lasted for about 8 days and then it went away as fast as it came.

Two days after receiving the vaccine, the front of my neck developed a very itchy, warm rash, my lymph glands on the right side of my neck swelled so much that it was difficult to swallow even liquids without pain, and I had a fever of about 100. The itchy area on my neck continued to worsen, and despite the application of OTC anti-itch medications and me taking Benedryl, it got larger and warmer, and the itching became even more severe. At one point my throat was so swollen, I started to think it was closing up and that I'd need to go to the hospital. The discomfort continued into the next day when I contacted Teledoc, and was prescribed an antibiotic, and prednisone, which helped. The itching is still present, but managed by regular spraying of an aerosol cortisone. And the swelling has gone, but there are slight scars like one would get from a scrape. My throat is much better, and my fever is gone.

AFTER ABOUT 45 MINUTES OF RECEIVING THE VACCINE, MY BOTTOM LIP STARTED TO TINGLE. WITHIN A FEW MINUTES OF THAT A HIVE APPEARED RED AND MY LIP STARTED TO SWELL. I TOOK BENADRYL, WHICH SEEMED TO HELP STOP THE SWELLING.

Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.

4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with bleeding sores on tongue and side of mouth. Began to have bruises on arms, feet and legs. Blood in urine and bruises on back. Presented to emergency department on 4/11/21. CT brain revealed a right sided posterior temporal hemorrhage. Patient was emergently treated with platelets, DDAVP, factor VII, Decadron, IVIG. 4/12/21, patient denies headache, changes in vision, double vision, change in sensation, including burning, pinprick, numbness, no focal or motor weakness. No change in bowel or bladder control. No sensory changes. Patient states she is now back to her normal state of health, save for the bruising described.

Broke out in itchy, swollen, red rash. Began as single spot on right eyelid withing 4 hours of receiving vaccine. Spread over first week, across temple and forehead and chin, later on belly (which spread to cover 1/4 torso below waist on front side), between legs on both sides at top of inner thighs, latter on outer thighs of both legs. Felt like needles pricking skin if fabric touched skin. Lasted three weeks. However, at three weeks I am sill not over the rash. I can now function normally, even though the skin is still red and slightly itchy. Oddly, the rash was strong on the right side of my body with a fainter mirror image on the left side. I reported all this on the V-SAFE app.

April 12th - 4:30 pm and on - I was very tired and groggy April 13th - 7:30 am until 10:00 pm - I had a headache, nausea, no appetite, chills, fever up to 101.6, constipated and overall felt crappy - slept most of the day. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 14th - 7:15 am - 11:00 pm - I had a headache (not as bad as previous day, nausea, no appetite, chills, fever up to 99.4, constipated and overall felt crappy - slept a bit less than previous day. Between 2:00 am and 6:00 am, I believe the fever broke - sweats were consistent. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 15th - 7-20 am - current - All above listed symptoms have gone away. I also had a bowel movement twice today. I feel a bit tired but almost back to normal.

On day two after second vaccination, a red taut swelling at innoculation site (left arm) appeared. It was not there on day one or after first dose. Increased in size as day went on and became itchy. Day 3, woke up to again an increase in size of taut red swelling (original size was about 1/2" x 1", by morning of Day 3 it was 1.75" x 3") and there is notable, consistent itching on left hand (same side as vaccinated arm) between base of index and middle fingers. (There was some itching there on day 2 but was too randomized to be sure if it was psychosomatic response.)

Patient had prior allergic reaction to tetanus shot in 2007. Also given diagnosis of mast-cell disorder, she pre-medicated with Benadryl 25mg, then received the vaccine. After about 15 minutes, she started to feel itchy and transient chest tightness. No rash noticed pulse-ox 98-100%, Heart rate 75 and BP 123/80. She was given 25mg more of Benadryl and observed for another 20 minutes. She said her symptoms has completely resolved and she went home with her husband after being given strict instructions to return.

sever itchy on palms, fingers, in between fingers, foot, forehead, side of right thigh, right side cheek on face , eye lashes NO RASH, NO REDNESS (other than where i scratched) took benadryl an hour and a half after intitial problem with in 30 minutes itchiness subsided but not totally gone

Patient received her 2nd dose Covid vaccine and approx one hour after the dose had slight throat edema and redness of her throat and chest. No lips/airway involvment. She had premedicated with zyrtec per her MD and received 25 mg PO Benadryl at 1500 in the tent. Her home epipens are at her side as well as her inhaler. Started to cough and have some throat itchiness approx 30 mins later. Escorted to ED.

Rash (look like large insect bites - larger red bump and very itchy)upper left arm near injection site, further down and around arm, up halfway to neck, on left chest area, couple on side abdomen. All on left side of body. No rash on right side.

Day after 2nd dose patient developed erythematous rash with underlying edema on legs and back. 7 days later patient developed similar rashes on forearms and arms. Rash is made up of papules with surround erythema/edema (~5cm max diameter) and is pruritic and burning. Associated myalgias and fatigue

Large welts on left arm with rash and numbness and tingling and pain, happened in less then 24 hours of vaccination

I had some site soreness for several days...nothing too bad. Took some Tylenol for it. Two days after injection I got pretty bad diarrhea that lasted several days. I also got the chills/shakes the second night. Then I got a pretty bad Eczema flare...on my breasts. It continues at week two. My left armpit HURT terribly for almost a week. Tylenol did not relieve it at all. I also had quite sore Lymph nodes across my chest/side of neck.

Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful. The issues move from area to area and seem to inflame fatty areas most. I thought this would go away and didn't document with pictures, like I should have. I now have a couple of pictures and will continue to do so. I've tried hot baths, cold packs, hot packs, elevating the area and topical relievers. I couldn't feel the heat of the pain reliever on the affected area. This has been absolutely debilitating and I've had to miss some work because of it.

Received shot around 1:10pm, a few hours later around 4pm felt tired. Pain at injection site lasted a few days felt like a bruise. Around 8:30pm lips became bright red, felt like there were sores on the roof of the mouth that were painful and interfered with eating for 3 days after shot ate soft foods, eyes really dry, extremely thirsty for about 2 days after shot. On 4/3/21 around 9pm took a 25mg tablet of Benadryl and that helped a little bit with the symptoms. On 4/13/21, 10 days after the shot, felt extremely fatigued, body and joint aches intense, nauseated, headache lasted a couple of days. By 4/16/21 felt better and was able to go to work in retail.

Day after injection: painful injection site/ upper arm, body aches. Three days later: diarrhea lasting about 6 hours, until anti-diarrheal pills took effect.

3/23 pain points - complaint of bug bites - no bites seen; 3/24-3/30 small red spots appearing to be itchy bug bites that would not subside. Topically using cotton balls saturated in apple cider vinegar. 3/31 itching on small sites and intense pain. 4/1-4/6 hot baths with apple cidar vinegar and epson salts seem to stay itch - no blisters seen. 4/7 pictures were taken after baking soda bath with apple cider viinegar produced large red splotches. Called 24/7 hotline on evening of Friday or Saturday 4/8 or 4/9 - Dr. did not think what I described was shingles because no visible blusters. Take Tylenol with coding (300 mg 0n hand) and 2 hours later take 4 ibprofen. No fever

My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.

There were originally two specific lumps on the first day then merged into one large lump at the injection site after approximately 30 hours. The area of the lump is reddish in color and warm to the touch. The current size is approximately 1.5? x1?. It is now 76 hours after the shot.

The morning after being vaccinated I had an elevated temperature of 100.1, headache, and body aches all of which were gone the next morning. I also experienced a sunburn like rash on the inside of my arms and legs and on my torso front and back. The rash was painless, not itchy and similar to the rash I get when I take an antibiotic that I am allergic to. The rash gradually subsided. The arm I received the injection in was sore for a few days.

I had a full blown red rash all over my body; red lesions all over my leg and my back and red marks and scratches all over my chest, my back, legs; it downed the swelling and the itch but I still have red rashes and scratch and red marks all over my body; had a severe reaction; The next day after vaccine I had extreme hives, red welps all over by body from head to toe; This is a spontaneous report received from a contactable consumer. A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on Left arm on 24Mar2021 12.00 at single dose for covid-19 immunization and second dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on Left arm on 24Mar2021 12.00 at single dose for covid-19 immunization. Relevant medical history includes Von Willebrand Type 2 bleeding disorder. Concomitant medications include Lisinopril. It was reported that the next day after vaccine I had extreme hives, red welps all over by body from head to toe on 25Mar2021 at 13.00 PM and treated with Prednisone/Atarax and resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient not diagnosed with COVID-19. Patient weather tested positive for COVID-19 since having the vaccine is unknown. Upon follow up on 31Mar2021, there wasn't side effects with the first shot, it was with the 2nd shot, developing rash on the second day, red rash, welts, swollen, severe scratch marks on chest, swelling on shoulders and welts, arms with welts and scratch marks, and major scratch marks and welts on lakes, and big old red patch on my left calf. The next day went to Clinic and saw a doctor, he couldn't even believe it, he was gasping at what he saw, gave me prednisone for severe allergic reaction, today is the last day of treatment, I started prednisone on Friday and the last day is today. It did take down swelling itching and pain, now I am left with patches, welts, scratches on my chest and red lesions and big red patch on my left calf. Can send pics if you want. I want to know how to get rid of the patches, or when will they go away? can you suggest what I can take? I am going to go to a haematologist next week, because I do have a bleeding disorder. It looks to me like these are going to be the scars and they are not going to go away. It feels like someone took their nails and just scratched., looks like they aren't going to go away. " Response: Spoke from attached document: explained that Pfizer is unable to provide treatment and management recommendations and referred to HCP. Offered to email document for review with HCP, and for links for latest information and reporting. Upon follow up on 31Mar2021, I had my 2nd vaccine of the Pfizer Vaccine on 24Mar2021 and the next day I started seeing a rash, mild rash and then on the 25mar2021 I had a full blown red rash all over my body and red lesions all over my leg and my back and red marks and scratches all over my chest, my back, legs and so I went to my doctor on the 26mar2021 they prescribed Prednisone and so I am on my last of the Prednisone, it downed the swelling and the itch but I still have red rashes and scratch and red marks all over my body, I had a severe reaction." Consumer stated, " I took pictures, so I can send them, so they can see what it did I don't know. Well I wanted to see like what Pfizer can do to help me, this is like not going away any time soon, I going to see another one of my doctor next week." Consumer was informed about the role of Pfizer Drug Safety and permission to probe: consumer stated, " Well actually I'm expecting a call from my doctor, I need to take his call." The outcome of the events for "Urticaria" was "Not recovered", for "Rash", "Skin lesion", "Swelling", and for "Reaction aggravation" was "Unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up (31Mar2021): New information received from a contactable consumer: New clinical information (Product details, and new adverse event information) added. Follow-up (31Mar2021): New information received from a contactable consumer: New clinical information added. No follow-up attempts are needed. No further information is expected.

anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.

Topical Rash developed at site 7 minutes post injection. VS stable. Medical Director consulted. Will monitor for additional 15 minutes. No additional symptoms. Released home -no intervention.

having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.

Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.

Tingling and burning on 4-17-2021, on upper lefthand side of back. Burning, stinging pain on 4-18/2021 and 4/19/2021, same area. Rash broke out and it was diagnosed as shingles on 4-20-2021.

Woke up early the night of the shot with severe pain in left are below shoulder where shot was given. My arm has been painful to move..I thought would eventually go away but never did. Three weeks later still very painful and makes my job even more painful to do. It's a continual ache and hard to move.

After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.

Patient started complaining of numbness to the right upper quadrant and later developed itchiness throughout body. Patient evaluated by RN and EMS. Patient remained in observation for about 45 mins . Symptoms alleviated and was recommending to drink fluids and take benadryl over the counter at home. Patient then returned as she started developing heavy tongue and numbness to the lips while on her way home. Patient denies any shortness of breath , no chest pain, no dizziness , no nausea. At 1207 pm- Patient was evaluated by Dr. and was advised to administer Benadryl 25 mg IM and advised patient can take another 25 mg of Benadryl PO at home. At 1214pm Paramedic administered 25 mg of Benadryl IM on right arm . 1231pm patient reports feeling better , symptoms have resolved. Patient advised MDs recommendation to take benadryl 25 mg by mouth. Patient advised if symptoms worsen and/or develop shortness of breath contact 911 or go straight to ER.

The patient had a localized rash near the injection site. The patient was told to monitor the rash and report to the ED if symptoms continue or worsen.

On 4/18 had fever and aches, but was better and able to work on 4/19. Rash broke out on 4/20 on R anterior shin (somewhat linear set or erythematous papules - look like broken vessels from when an area is scratched, but she denies scratching; lesions don't blanch), back of neck (wide area of erythematous maculopapules with a hint of some mild swelling/raised appearance), over L hip. Patient reports that it doesn't itch or hurt. She did think they were swollen at a point. Patient is also feeling a bit dizzy, with some nausea and a little diarrhea.

face and throat swelling and redness; face and throat swelling and redness; mild face swelling; lymph nodes swelling in armpits; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number: ER8737 and expiration date was not reported), via an unspecified route administered in right arm on 31Mar2021 at 12:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. The patient's medical history included ductal carcinoma in situ (DCIS). The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported), via an unspecified route of administration, date and dose for COVID-19 immunization. The patient was not pregnant. It was reported that no other vaccine was given in four weeks but patient had received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced mild face swelling and lymph nodes swelling in armpits on day 1 (01Apr2021) after vaccination. On day 2 and 3 after vaccination, the patient had only mild face swelling. On day 4 (04Apr2021), the patient experienced severe face and throat swelling and redness. The patient rushed to the emergency room (ER) but conditions reduced by 80% by the time of arrival at the ER. The patient took diphenhydramine (BENADRYL) tablets and the doctor prescribed an epinephrine autoinjector (EPIPEN) and told her to keep on hand. From day 5 to day 8, mild facial swelling still exits. On day 9 (09Apr2021), patient had just a trace of facial swelling. It seems like conditions were getting normal. The outcome of the event facial swelling was recovering at the reporting time. The outcome of lymph nodes swelling in armpits and severe face and throat swelling and redness was recovered at the reporting time on Apr2021. No follow-up attempts are possible. No further information is expected.

Fever, chills, body aches lasted for 6-7 hours the day after the shot , sore at injection site for 3 days.

shortly after receiving the 2nd covid shot I broke out in a rash on my stomach and back. It was mostly on the the left side . I was given prednisone and it helped until the dose was reduced and then it came back. I have used all kinds of creams and nothing helps. I never had a problem with my skin until I got the vaccine.

Mark at injection site; Mark on the back left shoulder blade; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6203, expiry date unknown) on an unspecified route of administration on Arm Left on 14Mar2021 (at the age of 61-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Solution for injection; Lot Number: EL9269, expiry date unknown), on an unspecified route of administration on 21Feb2021 as single dose for COVID-19 immunisation. Two days after the second dose on 16Mar2021, the patient got mark on the injection site on the left upper arm and in the back of the left shoulder blade. The patient reported that both marks were black in colour and the mark on the arm was bad. She went to the doctor and he couldn't say anything, said it was just a reaction from the injection. She clarified that both marks are black in color, and both on the left arm, she clarifies that one mark is Not on the forearm but what she meant to say was the injection site on the upper arm and the second mark is on the back left shoulder blade. She has taken pictures and is willing to provide it to the safety department. The Marks have no texture to them, but they are getting better, the darkness is fading away, its not as dark. The outcome of the events was reported as recovering. No follow-up attempts are needed. No further information is expected.

Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating pain/shoulder pain/given high on the top of her shoulder. It hurt; sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 61-years old via an unspecified route of administration on 19Mar2021 10:10 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included systemic lupus erythematosus from 1985 and ongoing, arthritis and osteoarthritis from an unknown date and unknown if ongoing (She has osteoarthrosis throughout her body and her feet). Family history included stroke (husband died at the age of 59, he was having stroke upon stroke). The patient's concomitant medications were not reported. It was reported that when she received the shot, it was given high on the top of her shoulder and it hurt. She could not move her arm for 3 days. The pain was excruciating. On the 4th day, her arm was sore, but she could move it. She had no fevers, she didn't get sick, but she just couldn't move her arm. The shot was given at at 10:10 am, and by noon she could barely move her arm. Her left side of the mouth doesn't want to work properly. Her Bells Palsy started on 05Apr2021. She was in her car and driving to the store, when all of a sudden her left eye was watering. She got home and she didn't see anything wrong with her eye, except it was watering. She could tell a difference between the left and right side of face when she touched it. Something was wrong with her right side. Her eye was not opening all the way, it's been dropping, and her lip was down. She can't smile, and when she drinks water it's comes out. The patient clarified that it was her left side that is drooping. She went to the emergency room due to Bell's palsy. She could not move her arm within 2 hours of getting the shot. The patient mentioned her whole body aches from the Lupus and arthritis, but the shoulder pain was different after the vaccine. The shot itself hurt, and she thinks the one who administered the vaccine might have hit something. There's not a day that doesn't go by that she is not in pain. Her platelets are 200, which is very low. The patient underwent lab tests and procedures which included activated partial thromboplastin time: unknown result, blood glucose: unknown result, computerised tomogram: unknown result, full blood count: unknown result, glomerular filtration rate: unknown result; all on 06Apr2021, magnetic resonance imaging: showed a darkened area in her brain that looks like its connected with Bells Palsy on an unspecified date, basic metabolic panel: unknown result on 06Apr2021, platelet count: her platelets are 200, which is very low on an unspecified date, prothrombin time: unknown result, troponin i: unknown result (High sensitive ); both on 06Apr2021. The patient did not recover from Bell's palsy, recovered from vaccination site pain on 23Mar2021, from sore arm on 19Mar2021 and the outcome of the remaining event was unknown. Information about Lot/batch number is requested.

Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and slept all night; She just gets hot; Feeling unwell; blood pressure was out of control; lymph nodes are not as bad, they are hurting; She is having hot flashes; Tiredness/ she is still tired; Muscle and joint pain; swollen lymph nodes under arm; muscle and joint pain; Chills; Headaches; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8732 or LR8732) first dose on 03Apr2021 08:30 on right arm at single dose for COVID-19 immunization. Medical history included ongoing High blood pressure (Has had a long time), Breast cancer (Has had 6 years) and covid in Feb2021. History of all previously immunizations was No. Prior vaccincations wtihin 4 weeks was No. AE's following prior vaccinations was No. Concomitant medications included anastrozole (ARIMIDEX, strength 20 mg) for breast cancer (Has not taken the last 3 days, Did not want to take with the shot), bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HCT) for Blood pressure (States that she was taking 5-6.25mg and increased dose to taking 10 in the morning and 5 at night) and ongoing Vitamins. States that in Feb2021 had Covid and had gotten over that and was discharged. States that she might have had mild Covid and with all of the variances coming out, she wanted to get the vaccine. States that she got her first dose on Saturday (03Apr2021) and didn't know if she hadn't waited long enough. Caller states that she has been having terrible reactions. Has been having injection site pain but even had that with the flu shot. States that she has been experiencing tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. Has also been experiencing nausea and can hardly hold her head up. States that she slept all day yesterday, and slept all night. Woke up this morning feeling a little bit better, then the side effects took a hold of her again. Caller states that cancer meds made her gain weight and hasn't been able to get rid of it. Noticed Tiredness yesterday (04Apr2021) when she woke up. States that she had the vaccine on Saturday the 03Apr2021 at 8:30am, started to have headache that night. States when she woke up yesterday (04Apr2021), she started experiencing all of the other symptoms, tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. States that when she woke this morning, had thought everything was a little better but, then it hit her again. Clarifies she is still tired, and the headache still has not gone away. This morning (05Apr2021) she is having hot flashes, not so much the chills. The chills are still there but not nearly as bad, she just gets hot. She has been experiencing nausea and feeling unwell. States that the lymph nodes are not as bad, they are hurting but, not as bad. States that it is hopefully doing what it is supposed to do. States that she has been taking only Tylenol but has not taking it yet today. States that she is super scared to get the second shot. If this happened with the first shot, is terrified for the second shot. States that she has been taking Tylenol every four hours and is such a lightweight that she has only been taking one Tylenol every four hours. Caller states that she is supposed to be back 24Apr2021 for second shot but does not know if she can go through with it. States that this was recently increased when her blood pressure was out of control when she had gotten Covid. States that she was taking 5-6.25mg and her dose was increased dose to taking 10 in the morning and 5 at night. States that she is not taking as prescribed but she was too chicken to take the 10mg. States she will be back to see her doctor on 16Apr2021. States that she hates taking any medicine. Tests: States that she had bloodwork done Friday (02Apr2021) but has no idea of the results. States she will be seeing her doctor 16Apr2021 to go over the results. Vaccination facility type was Hospital drive up. Vaccine administered at military facility was No. No events required to ER. Caller states she has contacted her doctor to find out about her future vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness; Anaphylaxis-swelling of eyes, tongue, and injection site.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 05Apr2021 16:00 as single dose for COVID-19 immunization. Medical history included known allergies: yes and hypertension. The patient was not pregnant. Concomitant medications included metoprolol succinate (TOPROL XL), lisinopril dihydrate (LISINOPRIL), and cetirizine hydrochloride (ZYRTEC). The patient had no other vaccine in 4 weeks. On 05Apr2021 16:15, the patient experienced anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness. The events resulted in emergency room/ department or urgent care. Therapy for the events included prednisone, antihistamine, and intravenous (IV) fluid. The patient did not have covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering. Information about lot/batch number has been requested.

discovered a sore early the next morning that appeared to be the type from a blister where the blister skin had been pulled off. This sore was 1inch by 1inch approximately on my right buttocks near the base of my spine.

After 2nd shot within 24 hours my arm swelled up and became itchy , achy and red . As the night progressed it became worse and now 3 days later my arm is swollen, itchy, achy, and red from my elbow up to my shoulder at the place of injection. Went and seen my Dr. today.

Shingles diagnosed on April 8, 2021 Valtrex was prescribed and taken for 7 days - resolved. Currently PVC's, appointment scheduled for May 17, 2021. Not resolved.

Vaccine was administered by Health & Human Services, 1st dose on 2/11/2021 and 2nd dose on 3/4/2021 (both vaccine at 3:00 PM). Shingles later developed on the left arm as well as respiratory problems. Visit to regular GP on 4/22/2021 resulted in RX for Valacyclovir 1GM tablets, methylprednisolone tablets USP dosepak 4 mg, Breztri inhaler to accompany Albuteral inhaler. Currently on day 4 of 7-day regimen. Breathing is vastly improved and shingles are drying out and clearing up. Recovery progressing and ongoing.

Red blotchy skin within 20 minutes, itching. raised hives. Next 5 days followed by red flushing skin. Itching. Swollen throat and tongue.

Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium

at 1200, pt c/o "itching" at injection site "like a bee sting". No hives, swelling noted. Pt stated this is "how I feel when I have an allergy". Stated she "takes benadryl" for this. Observed. At 12290, pt c/o "lower lip feels itchy". Pt requested Benadryl; given 50 mg po Benadryl. At 1245, pt stated she was feeling "better", elected to go home and left vaccination clinic.

I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.

the site was swollen and red, draining pus; the site was swollen and red, draining pus; the site was swollen and red, draining pus; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received the first does of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Mar2021 13:15 (Batch/Lot Number: EN6204) (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, spinal neuropathy and allergy to latex. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Past drug history included the patient had allergy to acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the site was swollen and red, draining pus and she cleansed the area and it was size of a walnut. The area opened on its own with a moderate amount pus. The patient had no fever. She had been cleansing and keeping the area clean and dry. She kept applying antibiotic and cove. It was red but no drainage. It had not spread. The patient had no other symptoms. The outcome of events, the site was swollen and red, draining pus was recovering. No follow-up attempts are needed. No further information is expected.

Patient developed gum bleeding and petechiae several hours after the second vaccine dose was given. The next day she had hematuria and worsening bleeding and severe headache. She presented to hospital on 4/11/2021 and was found to have ITP and intracerebral hemorrhage.

Had typical body aches during first 36 hours post 2nd shot (had no reaction to 1st dose). In addition, at about 24 hours after getting 2nd dose, I developed hives. First patches on upper back and front of torso. Hives spread each day to a new location on lower back, upper legs and arms, butt and eventually in crevices at elbows and behind knees. Each patch dried up after 2-3 days. Whole episode lasted 9 days, then poof, gone. Since hives weren't terribly itchy (except after shower or if rubbed by clothes), I didn't take any antihistamine or put cream on them.

Patient left facility after vaccine and had only waited 12 minutes in lobby. Patient states she walked to her car to go home and developed metallic taste in her mouth with nausea and diaphoresis. Patient came back into the clinic. She was placed in the cardiac care chair. Denies any shortness of breath, chest pain, difficulty swallowing or hives. Skin warm but she is diaphoretic. BP 144/70, pulse 71, pulse oximeter 100%. Patient states she still has nausea and feels like vomiting. After 10 minutes, patient transferred to ER at hospital.

Pt received first dose of Pfizer at 2:33 pm. While waiting in observation after 30 minutes (3:03 pm), pt notified nurse of development of rash to both left and right arms. 2 nurses responded, assessment done- no difficulty of breathing observed, observation nurse stated VS stable, pt denied any other symptoms. Nurse offered Benadryl, pt refused, pt insisted she wanted treatment of her rash at a hospital. Stated she will drive her straight to Hospital Emergency Dept.

Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with leg very sensitive and burning feeling; then got more severe along with leg very sensitive and burning feeling; severe stomach pain; This is a spontaneous report from a contactable other HCP (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (at 61 years old), single dose for covid-19 immunisation. Medical history included concussion, endometriosis, all from an unknown date. Concomitant medications included estradiol; progesterone. No other vaccine in four weeks. On 28Jan2021 09:00, patient experienced Headache at work after vaccine , then got more severe along with leg very sensitive and burning feeling, better then 5 nights very severe stomach pain-Dr appt and ER to get sonogram, CT-Very late diagnosing as shingles. The outcome of the events was not recovered. Treatment of adverse events was CT, Sonogram. No covid prior vaccination. Not covid tested post vaccination. No Known allergies. Information about lot/ batch number has been requested; Sender's Comments: Based on known disease pathophysiology, the event herpes zoster is assessed as not related to suspect vaccine BNT162B2.

Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

Lower back discomfort/mild joint pain Mild injection site pain Large swelling/redness at site for a week Mild/moderate loss of bladder control Vertigo/nausea Lethargy Chills/fever 102.9 Congestion/cough Headache Unwell for about 24 hours

Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours

Headache at work after vaccine; leg very sensitive and burning feeling; leg very sensitive and burning feeling; very severe stomach pain-Dr appt and ER; shingles; This is a spontaneous report from a contactable other health professional (patient). A 61-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 61-years-old), administered in Arm Left on 28Jan2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included concussion (years ago) and endometriosis (decades ago). The patient was not pregnant. Not diagnosed with COVID prior vaccination. No known allergies. Concomitant medications included estradiol (ESTROGEN) patch and progesterone cream: taken for unspecified indications, start and stop dates were not reported. The patient experienced headache at work after vaccine, then got more severe along with leg very sensitive and burning feeling (all on on 28Jan2021 09:00), better then 5 nights very severe stomach pain (unspecified date in 2021)-Dr appt and ER to get sonogram, CT. Very late diagnosing as shingles on an unspecified date in 2021. The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included computerised tomogram: shingles on 2021 and ultrasound scan: shingles on 2021. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered. The vaccine facility type was hospital. No other vaccine in four weeks. Not tested for COVID post vaccination. Information on the lot/batch number has been requested.

Swelling, itching at vaccine site. Mild headache for a couple of days. Woke up about 36 hours after feeling fatigued. But sometime after that, either on 5/7 or 5/8, I started having leg pain in my left upper thigh, just below buttock. Some cramping in calves at night over the weekend. The upper leg pain has been pretty uncomfortable, but it doesn't appear red or swollen and I don't appear to have any other symptoms. I'm not planning to seek medical treatment unless something else happens. And, it could be completely unrelated! I'm only reporting it to contribute to the overall scientific information.

1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blisters; felt quite ill/not feeling well; second dose- extreme pain in left hand/sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 08Mar2021 (Batch/Lot Number: EN6208) (at the age of 61-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included breast cancer (2-time breast cancer survivor), had lymph nodes removed, and has low thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for low thyroid from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; famotidine (PEPCIDAC) taken for an unspecified indication from an unspecified start date and ongoing; esomeprazole sodium (NEXIUM) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took shingles vaccine on an unknown date (reported as number of years ago) for immunization, flu shots on an unknown date for immunization and also previously took the 1st dose of BNT162B2 (Batch/lot number: EN6200) (at the age of 61-years-old) on 15Feb2021, intramuscular administered in the right arm for COVID-19 immunisation, and experienced injection site pain in right arm, sore arm and swollen gland. Patient stated having what was considered typical, like a sore arm and did have some swollen glands with the first and second dose. It was also reported that after 1st and 2nd dose, there was injection site pain in right arm. After second dose she developed shingles, or what was later found out to be shingles, she had extreme pain in her hand. She thought it was injured or something, it was very painful. She got shingles blisters on her hand, and then also got some on her arm, the opposite arm as the injection. Her dermatologist and internist verified it was shingles. Her internist said it may have been triggered by the vaccine. She clarified it started in the palm of her hand and then traveled up her arm on the opposite side of the vaccine, she got the vaccine in the right arm and the shingles in the left arm. She felt quite ill as a result of the shingles. Her dermatologist put on Valtrex, three times a day. It helped with the spread; it stopped spreading. Her dermatologist was not associating it with the vaccine, and she was not sure she was either. After not feeling well for several days she told internist and he was confident that the vaccine was what caused the shingles. She doesn't remember for sure the event extreme pain in left hand, but it was within a few days after the 2nd dose. The swollen glands started within 24 hours, as well as, the sore arm. It wasn't anything she didn't expect. Like with the flu shot maybe a little worse, but it wasn't severe. Her sore arm was not ongoing. It recovered completely by the next day. Swollen glands came back when the shingles first happened, but they initially began within 24 to 48 hours, for both doses. After the second dose she took two extra strength Tylenol again on the first night again; she just took it once after the 2nd dose. Pain in the hand was 98 to 95 percent better. Her doctor did whole blood work up (unknown results) just to see her white count (unknown results) to rule out something else. The blisters were too small for the dermatologist to scrape and get a biopsy. She did not get the most current 2 dose vaccine for shingles, she only got one dose and that was a number of years ago, she was going to get it but then COVID happened. The outcome of event herpes zoster and pain in extremity was resolving while for other events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.